| 1 |
Anesthesia machine |
A medical device used to generate and mix a fresh gas flow of medical gases and inhalational anaesthetic agents for the purpose of inducing, monitoring and maintaining anaesthesia. |
C |
| 2 |
Aerosol delivery tubing |
A flexible tube used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer, intended for the delivery of aerosolized humidification, typically oxygen enriched. |
A |
| 3 |
Aerosol face mask |
A flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. |
B |
| 4 |
Aerosol inhalation monitor |
A device that enables a medical professional to objectively assess in detail how the test subject uses their inhaler. |
B |
| 5 |
Airway device cleaning utensil |
A hand-held device intended to be used to clean an in situ and ex situ airway device. |
A |
| 6 |
Airway pressure alarm |
A device connected to the breathing circuit that monitors a patient's upper airway pressure during assisted mechanical ventilation. |
A |
| 7 |
Airway pressure/oxygen monitor |
A device intended to continuously measure and display the breathing circuit pressure and oxygen (O2) concentration levels of respiratory gases delivered to a patient through positive pressure ventilation systems. |
C |
| 8 |
Airway protection face mask |
A flexible, form-shaped device that is placed over the nose and mouth to provide respiratory protection. |
A |
| 9 |
Airway temperature monitoring system |
An assembly of devices used to continuously measure the temperature at a specific point along a ventilation airway. |
B |
| 10 |
Airway tube forceps |
A hand-held instrument used for grasping a tube for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways. |
A |
| 11 |
Anaesthesia breathing circuit |
An assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient. |
B |
| 12 |
Anaesthesia catheter Luer connector |
A device intended to create a mechanical union between an anaesthesia catheter and an external device, via a Luer connection. |
A |
| 13 |
Anaesthesia depth monitor |
A device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anaesthesia), showing the degree of consciousness. |
B |
| 14 |
Anaesthesia depth simulator |
A device intended to simulate the electroencephalography (EEG) signals of an unconscious patient (in a state of anaesthesia) in order to test and calibrate an anaesthesia depth monitor, check patient cable continuity, or train healthcare providers. |
A |
| 15 |
Anaesthesia information system |
A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of anaesthesia services. |
B |
| 16 |
Anaesthesia instrument table |
It is intended as a support for Anaesthesia instruments used during general anaesthesia surgical procedures. |
A |
| 17 |
Anaesthesia mask stabilizer |
A device intended to secure an anaesthesia mask on the face of a patient typically by providing anchorage for the fixation of the mask's headstrap. |
A |
| 18 |
Anaesthesia system leakage tester |
A device intended to test an anaesthesia system for leakage. |
A |
| 19 |
Anaesthesia vaporizer |
A device used to vaporize the anaesthetic agent and deliver a controlled amount of the agent to a patient being prepared for surgery. |
C |
| 20 |
Anaesthesia warmer |
A device intended to warm the anaesthetic solutions prior to it being administered to a patient for anaesthesia. |
A |
| 21 |
Anaesthesia workstation gas scavenger |
A device intended to connect between the expiratory valve/port of a breathing circuit and the extraction system enabling the waste anaesthetic, exhaled, or other trace gases to be removed under controlled conditions from the work environment and channelled to the outside of the building. |
B |
| 22 |
Anaesthetic gas absorption/desorption device |
A device intended to, when integrated within the common line of a breathing circuit, absorb and desorb (i.e., recycle) exhaled volatile anaesthetic agents. |
B |
| 23 |
Anaesthetic gas scavenging terminal unit |
A device intended to function as an outlet assembly to which the operator can connect/disconnect an anaesthetic gas scavenging system (AGSS). |
A |
| 24 |
Anesthesia Face Mask |
A device designed to be placed over a patient's nose and/or mouth to administer anaesthetic gases to the upper airway. |
A |
| 25 |
Artificial airway stylet |
A device intended for insertion within the lumen of an artificial airway tube to stiffen and/or maintain the shape of the tube to facilitate intubation. |
A |
| 26 |
Artificial airway washing/disinfection jar |
A container intended to hold artificial airway devices to facilitate their washing/disinfection. |
B |
| 27 |
Atomizer |
A device that is intended to provide liquid medication in aerosolized form into the air that a patient will breathe. |
A |
| 28 |
Brachial plexus anaesthesia kit |
A collection of devices intended to deliver a brachial plexus nerve block through one of several routes that could include supraclavicular, interscalene, infraclavicular, or axillary. |
B |
| 29 |
Breathing circuit bag |
A device intended to store breathing gas during the respiratory cycle. |
A |
| 30 |
Breathing circuit condenser |
A device intended to be integrated within the expiratory limb of a breathing circuit to remove excess moisture through cooling and condensing, whilst also reheating the dried gases to an appropriate machine-compatible temperature. |
A |
| 31 |
Breathing circuit dryer |
A device that is used for the purpose of drying breathing circuit equipment that have been washed inorder to prevent bacteria growth and deterioration. |
A |
| 32 |
Breathing circuit gassampling/monitoring set |
A collection of devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis. |
B |
| 33 |
Breathing circuit washer/disinfector |
A device intended for the cleaning and high-level disinfection of breathing circuit components used in respiratory therapy and anaesthesia equipment. |
B |
| 34 |
Breathing mouthpiece |
A device intended to be inserted into a patient's mouth to facilitate access to the respiratory system. |
A |
| 35 |
Bronchial cannula |
A tube-shaped surgical instrument that is inserted into the lumen of the bronchus by means of a trocar blade to provide rigidity. |
A |
| 36 |
Bronchoscope |
An endoscope with an inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs and take biopsies and sample of secretions. |
A |
| 37 |
Bronchoscopy tube |
A device which is inserted orally into the trachea to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope. |
B |
| 38 |
Bulk oxygen concentration system |
An assembly of devices designed to concentrate oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 99.5%, to the hospital medical gas supply system. |
A |
| 39 |
Capnography oxygen mask |
A device intended to be placed over the nose and mouth to deliver oxygen (O2) to a patient's airway and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status. |
A |
| 40 |
Capnography sampling adaptor |
The device is intended for sampling CO2 and use with monitors enabled with capnography technology. |
A |
| 41 |
Carbon dioxide monitor |
A device intended to continuously measure the concentration of carbon dioxide (CO2) in a gas mixture to determine a patient's ventilatory, circulatory, or metabolic status. |
C |
| 42 |
CPAP/BPAP nasal mask |
A device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). |
B |
| 43 |
CPAP/BPAP oral mask |
A device designed to be fitted to the user's mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). |
B |
| 44 |
Electronic epidural space locator control unit |
A device intended to be used with an epidural needle and an electronic epidural space locator pressure-sensing set, to aid a user in locating the epidural needle tip within the epidural space for subsequent anaesthesia administration. |
D |
| 45 |
Electronic oesophageal stethoscope |
An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. |
B |
| 46 |
Endobronchial airway sizing kit |
A collection of mechanical devices intended to be used with a balloon catheter for a planned intervention to determine the appropriate endobronchial valve sizes for a patient's lung airways (bronchial lumens). |
A |
| 47 |
Endobronchial tube |
A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. |
B |
| 48 |
Endotracheal secretion monitoring system |
An assembly of devices designed to continuously detect the sound of endotracheal (ET) secretions moving through a ventilation circuit during suctioning of an artificially ventilated and/or spontaneously breathing patient to assess the effectiveness of suctioning. |
B |
| 49 |
Epidural anaesthesia kit |
A collection of devices intended to be used to deliver an analgesic or anaesthetic agent to the epidural space for pain management. |
D |
| 50 |
Helium/oxygen breathing gas mixer |
An independent mechanical device designed for accurate mixing of helium (He) and oxygen (O2) with concentrations that are appropriated for breathing in a patient who is indicated to assist flow of O2 into the alveoli and to reduce the work of breathing. |
B |
| 51 |
High-frequency ventilator |
A device intended to assist or control alveolar ventilation using a frequency that is considerably higher than the physiological breathing rate and a tidal volume less than or equal to the anatomic dead space. |
C |
| 52 |
Inhalational analgesia unit |
A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. |
B |
| 53 |
In-line arterial blood sampling set |
A collection of devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. |
A |
| 54 |
In-line backflow valve |
A general-purpose device used in medical tubing or pipelines to prevent the backflow of gases or liquids. |
A |
| 55 |
Intracardiac oximeter |
A photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation. |
B |
| 56 |
Intravascular blood gas/pH monitoring system |
An assembly of devices used for the continuous in vivo measurement and display of the values of pH and/or the partial pressure of CO2 and/or O2 in arterial blood. The system is used for patients with respiratory failure or severe pulmonary hypertension after cardiac surgery. |
B |
| 57 |
Intravascular membrane oxygenator |
A device designed for intravascular diffusion of oxygen into and carbon dioxide from the blood across an implantable (vena cava) gas-permeable membrane, used mainly as a temporary treatment for failing lungs in adults with respiratory distress syndrome. |
C |
| 58 |
Intravascular oximeter |
An instrument designed for the continuous in vivo measurement of venous blood oxygen saturation (SvO2) using a fibreoptic catheter. |
B |
| 59 |
Intubation laryngoscope |
A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. |
A |
| 60 |
Intubation teeth protector |
A device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. |
A |
| 61 |
Invasive arterial pressure cardiac output/oximetry monitor |
A device intended to continuously measure and display arterial pressure cardiac output (APCO) and haemoglobin oxygen saturation (e.g., SpO2) when connected to an extravascular blood pressure transducer linked to a peripheral arterial line, and to a pulse oximeter or an oximetry catheter. |
B |
| 62 |
Laryngeal airway |
A curved tube used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. |
A |
| 63 |
Laryngeal airway introducer |
A device intended to aid insertion of a laryngeal airway into the pharyngeal cavity of a patient while reducing or eliminating the need for finger manipulation within the mouth. It is typically in the form of a metal blade with a handle and may be mounted onto the laryngeal airway during insertion. This is a reusable device intended to be sterilized prior to use. |
A |
| 64 |
Laryngectomy tube |
A device intended to maintain tracheostoma patency after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis in the months following the procedure. |
B |
| 65 |
Laryngotracheal anaesthesia applicator |
A non-sterile container that is prefilled with an anaesthetic agent and intended to be used to apply the agent to the oropharynx and upper airway, to relax laryngotracheal reflexes prior to an intervention of an endotracheal (ET) tube or other type of tracheal tube. |
B |
| 66 |
Manual jet ventilation device |
A portable, manually-operated, noninvasive device intended to be used in conjunction with a separate compressed oxygen (O2) source and airway access device for transtracheal ventilation of a patient in an emergency situation where there is complete or partial obstruction of the airways. |
C |
| 67 |
Mechanical positive pressure airway secretion-clearing device |
A hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease. |
A |
| 68 |
Medical gas flowmeter |
A device intended to measure and regulate the flow of a medical gas during various procedures. |
A |
| 69 |
Medical gas flowmeter, Thorpe tube |
A device intended to measure and regulate the flow of a medical gas during various procedures. |
A |
| 70 |
Medical gas pipeline system |
An assembly of devices designed to supply compressed medical gases from a central source to endpoints throughout a medical facility. |
A |
| 71 |
Medical gas pipeline system automatic outlet analyser |
A mains component of a medical gas pipeline supply system that monitors the composition of a gas delivered from the supply system. |
A |
| 72 |
Medical gas pipeline system pressure monitor |
A component of a medical gas pipeline system designed to continuously monitor and detect changes in the pressure values of the medical gases in the supply pipeline. |
A |
| 73 |
Medical gas terminal unit |
A device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for a single/mixture of gas to which the operator can connect and disconnect a medical device. |
A |
| 74 |
Medicine chamber spacer |
A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. |
B |
| 75 |
Microbial medical gas filter |
A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy. |
B |
| 76 |
Nasopharyngeal airway |
A rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. |
A |
| 77 |
Negative-pressure ventilator |
An automatic cycling machine used to assist or control alveolar respiration that exerts a negative pressure on the external surface of the chest wall, expanding the chest and moving air into the lungs. |
C |
| 78 |
Neonatal chest percussor |
A hand-held device (a percussor) intended to be operated by a healthcare professional to provide external vibrations to the chest wall of a neonate to help loosen bronchial mucus for expectoration through suctioning. It is used to help loosen secretion build-up in the lungs of neonates who cannot perform the natural cough mechanism. |
B |
| 79 |
Nerve-block injection manometer |
A noninvasive device intended to be connected between a syringe and a nerve-block needle to indicate injection pressure during administration of local or regional anaesthesia to achieve peripheral nerve blockade. |
A |
| 80 |
Nitric oxide delivery unit |
A device intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders. |
B |
| 81 |
Non-heated respiratory humidifier |
A device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. |
B |
| 82 |
Non-rebreathing oxygen face mask |
A flexible, form-shaped device designed with a valve to control rebreathing and contamination of gas, placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway for oxygen therapy. |
A |
| 83 |
Nose clip |
A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function and/or to stop nosebleeds. |
A |
| 84 |
Oropharyngeal airway |
A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. |
A |
| 85 |
Oxygen administration hood |
A device consisting of a rigid transparent plastic shell forming an enclosure over the head of an adult, typically to provide an enriched oxygen (O2) environment to increase the patient's O2 uptake. |
A |
| 86 |
Oxygen saturation/pulse rate simulator |
An electronic instrument designed to simulate arterial oxygen saturation and/or pulse rate for testing and calibrating pulse oximeters, pulse oximeter probes and other related pulse oximetry devices. |
A |
| 87 |
Oxygen/air breathing gas mixer |
A portable mechanical device designed to mix air and oxygen (O2) for mobile O2 administration during first aid or emergency situations. |
B |
| 88 |
Oxygen/air/nitrous oxide breathing gas mixer |
A device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. |
C |
| 89 |
Patient physiologic monitoring system |
An assembly of devices designed for continuous assessment of several vital physiologic parameters of patient(s). |
C |
| 90 |
Peak flow meter |
A device designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. The device is typically intended to monitor the respiratory status of a patient suffering from chronic respiratory disease in a clinical setting or the home. |
B |
| 91 |
Pleural manometer |
A noninvasive device intended to convert pressure into electrical signals for the measurement of pressure within the pleural cavity. |
B |
| 92 |
Pneumatic chest percussor |
A hand-held pneumatic device designed to provide external vibrations to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. |
B |
| 93 |
Pressure algometer/aesthesiometer |
An instrument designed to measure a patient's sensitivity to pain (pain threshold) and tactile sensibility. |
B |
| 94 |
Pulmonary function analysis system |
A device used to measure the function of the respiratory system in adults and compliant children. |
B |
| 95 |
Pulmonary resuscitator |
A hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. |
C |
| 96 |
Pulse Co-oximeter |
A device designed to detect hypoxia via the transcutaneous multiwave measurement and display of carboxyhaemoglobin saturation (SpCO) and typically other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), and haemoglobin concentration (SpHb). |
B |
| 97 |
Pulse oximeter |
A device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). |
C |
| 98 |
Rebreathing oxygen face mask |
A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. |
A |
| 99 |
Respiration monitor |
A device designed to measure and display a nonambulatory patient's respiratory functions. Measurements include concentration of respiratory gas components and/or continuous monitoring of the inspiration/expiration cycle including respiration rate, air volume, and cessation of breathing (apnoea). |
B |
| 100 |
Respiratory oxygen monitor |
An instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting. |
B |
| 101 |
Respiratory oxygen therapy monitor/regulator |
An electrically-powered unit designed to be connected to a pulse oximeter sensor and used during the administration of oxygen (O2) to a spontaneously breathing patient, for: 1) continuous monitoring of physiologic parameters, especially haemoglobin oxygen saturation (SpO2); and 2) dynamic regulation of the amount of O2 delivered to the patient based on physiological parameter measurements. |
B |
| 102 |
Retrograde endotracheal intubation kit |
A collection of devices used to assist in the placement of an endotracheal (ET) tube during difficult/emergency airway access procedures. |
B |
| 103 |
Rigid non-bladed video intubation laryngoscope |
A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. |
A |
| 104 |
Saddle block anaesthesia kit |
A collection of devices designed to deliver an analgesic or anaesthetic agent to the lower dural sac in the region corresponding to the buttocks, in the perineum, or to the inner aspects of the thighs. |
B |
| 105 |
Spinal needle bioimpedance navigation unit |
A device designed to transmit and receive electrical signals to/from a dedicated spinal needle and to analyse bioimpedance data in real-time, to predict needle tip location. |
D |
| 106 |
Spirometer/pulmonary function analyser syringe |
A device consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary measuring/testing device for calibration or reference. |
A |
| 107 |
Tracheal surgery dilator |
A hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. |
A |
| 108 |
Tracheostomy kit |
A collection of surgical instruments, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. |
C |
| 109 |
Tracheostomy tube cannula |
A hollow, cylindrical, curved device designed as an internal, independent component of a metal tracheostomy tube. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, thereby preventing blockage and infection of the stoma and eliminates the traumatic removal of the tracheostomy tube. |
A |
| 110 |
Tracheotome |
A surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy). |
A |
| 111 |
Ultrasonic cough stimulation system |
An assembly of devices designed to stimulate a reflex cough using ultrasound in a patient who cannot cough on command, typically respiratory patients with cortical insufficiency or the very young/elderly, to help clear the lungs of secretions and aspirated materials. |
A |
| 112 |
Ultrasonic respiratory humidifier |
A device designed to agitate water into micro-particles with ultrasound to add moisture to the flow of air/gases administered to a patient via a breathing tube/circuit. |
B |
| 113 |
Vacuum-assisted airway secretion clearing system |
A device assembly designed to remove excessive secretion from the lungs and upper airway of patients with respiratory disease or during cardiac rehabilitation through vacuum technology. |
B |
| 114 |
Venturi oxygen face mask |
A flexible, cone-shaped device placed over the patient's nose and mouth to deliver a mixture of an almost precise ratio of air and oxygen to the patient's airway. The device usually has a replaceable part (Venturi tube) to change the mixture ratio of air and oxygen so that oxygen is delivered at a desired concentration. The device is connected to the oxygen source via a tube. The device has a head strap for fixation. Normally comes with an adapter to connect with humidifier. |
B |
| 115 |
Vortex oxygen face mask |
A device designed to be placed over the nose and mouth of a patient to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. |
B |
| CATEGORY:PAIN MANAGEMENT |
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| 1 |
Acupressure calf band |
A device designed to be worn around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome. |
A |
| 2 |
Acupressure wristband |
A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. |
A |
| 3 |
Acupuncture electrical stimulation system |
An assembly of devices used to apply electrical stimuli to acupuncture sites. |
B |
| 4 |
Acupuncture kit |
A collection of instruments and supplies used to perform acupuncture procedures. |
B |
| 5 |
Acupuncture point detector |
An electronic probe used to precisely locate an acupuncture point on a patient's body. |
B |
| 6 |
Analgesic PENS system |
An assembly of devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS). |
B |
| 7 |
Analgesic peripheral nerve electrical stimulation system |
An assembly of devices designed to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. |
C |
| 8 |
Analgesic spinal cord electrical stimulation system |
An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). |
C |
| 9 |
Analgesic TENS system |
An assembly of devices used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). |
B |
| 10 |
Arthritis TENS system |
An assembly of devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). |
B |
| 11 |
Arthritis transcutaneous electrical joint stimulation system |
An assembly of devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating an arthritic joint across the skin (transcutaneously) and to provide an overall improvement to an arthritic joint and defer or avoid surgery. |
B |
| 12 |
Bed/chair electric massager |
A device intended to provide therapeutic massage to the occupant of a bed or chair for the treatment of body aches and pains. |
B |
| 13 |
Bite relief pad |
A thin, plastic, horseshoe-like wafer that is placed between the upper and lower sets of teeth and bitten down on, or chewed, to help relieve pain or discomfort after orthodontic treatment. |
A |
| 14 |
Blue/red/infrared phototherapy lamp |
A portable device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). |
B |
| 15 |
Circulating-fluid thermal therapy system |
An assembly of devices intended to be used to pump heated and/or cooled fluid through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). |
B |
| 16 |
Cold-air therapy unit |
A unit intended to generate and deliver a stream of cold air directly to the skin surface to treat musculoskeletal/rheumatic disorders, to reduce localized pain/inflammation, and/or to reduce thermal skin damage during dermatological laser treatments. |
B |
| 17 |
Cryogenic analgesia unit |
A device designed to provide analgesia by applying extremely low temperatures to body tissues. It is used for postoperative and chronic intractable pain relief. |
C |
| 18 |
Deep-tissue electromagnetic stimulation system |
An assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders; 2) treat body pain; and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat. |
B |
| 19 |
Ear microsystem needle |
An instrument used in auriculotherapy to apply continuous pressure to stimulate meridian points. |
A |
| 20 |
Electric pad localized-body heating system |
An assembly of devices designed for the transcutaneous application of heat to a localized body site to relieve musculoskeletal pain. |
B |
| 21 |
Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system |
An assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) and pneumatic pressure wave therapy to treat musculoskeletal disorders. |
C |
| 22 |
Endothermic cold therapy pack |
A device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. |
B |
| 23 |
Epidural anaesthesia kit |
A collection of devices intended to be used to deliver an analgesic or anaesthetic agent to the epidural space for pain management. |
C |
| 24 |
Epidural/intrathecal anaesthesia kit |
A collection of devices designed to deliver an analgesic or anaesthetic agent into the epidural and subarachnoid (intrathecal) spaces around the spinal cord for pain management. |
C |
| 25 |
Exothermic heat therapy pack |
A device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. |
B |
| 26 |
Flexible fibreoptic epiduroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of intractable back and leg pain. |
C |
| 27 |
Foot bath |
A device designed to be filled with water to provide therapeutic heat treatment specifically to the feet. This device is intended to relieve foot pain as well as headaches, coughs, and other cold symptoms. |
B |
| 28 |
Heat therapy gel |
A non-sterile gelatinous compound in a container that is dispensed for application to the body surface to provide a warming effect for underlying tissues. It is intended to reduce/relieve pain, muscle tension, and to increase local circulation. |
B |
| 29 |
Hydrotherapy bath/tank |
A bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. |
B |
| 30 |
Ice bag |
Intended to alleviate pain and/or promote healing in minor injuries of the body or for application around the neck or limbs. |
A |
| 31 |
Ice collar |
Intended to alleviate pain and/or promote healing in minor injuries of the neck, throat, and/or head and to alleviate a sore throat. |
A |
| 32 |
Implantable intrathecal infusion pump |
A device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs to manage intractable pain and muscle spasms of malignant or non-malignant origin. |
D |
| 33 |
Implantable lumbar neuromuscular electrical stimulation system |
The system is designed to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain (CLBP). |
D |
| 34 |
Inflatable hot/cold therapy pack/electric pump |
An assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury. |
B |
| 35 |
Inhalational analgesia unit |
A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. |
B |
| 36 |
Interferential electrical stimulation system |
An device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies that cross-over/interfere, producing a beating frequency at the treatment point. |
B |
| 37 |
Intervertebral disc prolapse therapy pack |
A device intended to be applied to the skin overlying an affected area of the spine (cervical or lumbar) to reduce pain associated with a prolapsed (herniated) intervertebral disc. |
B |
| 38 |
Intubation teeth protector |
A device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. |
A |
| 39 |
Inversion table |
A fixed framework with a tilting table platform designed to support the body of a patient and provide traction for the back muscles and spine by allowing the patient manually invert their entire body in a supine position (feet up and head down), thereby assisting patients to eliminate/alleviate back pain. |
A |
| 40 |
Massage table/couch |
A table designed for various kinds of complementary therapy. |
A |
| 41 |
Medium-wave diathermy treatment system |
An assembly of devices designed to produce therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz, to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies. |
C |
| 42 |
Microwave diathermy treatment system |
An assembly of devices designed to produce therapeutic heat below the skin within specific volumes of the body through the transcutaneous transmission of high frequency electromagnetic (EM) energy, to promote tissue healing and pain relief. |
C |
| 43 |
Multi-modality physical therapy system |
An assembly of devices designed to apply multiple different energies either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders. |
C |
| 44 |
Musculoskeletal infrared phototherapy unit |
A device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury and to improve blood circulation in the treated areas to facilitate healing. |
B |
| 45 |
Musculoskeletal intense therapeutic ultrasound system |
An assembly devices designed to produce and deliver intense therapeutic ultrasound (ITU) waves through the skin to create ablative lesions in subcutaneous soft tissues, intended to reduce inflammation and pain associated with musculoskeletal disorders or injuries by stimulating collagen production and regenerating connective tissue. |
C |
| 46 |
Musculoskeletal/physical therapy laser |
An electrically-powered diode laser intended to provide noninvasive laser therapy for localized treatment of musculoskeletal conditions, improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. |
C |
| 47 |
Neurophysiologic monitoring system |
An assembly of devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction. |
C |
| 48 |
Pain-relief phototherapy skin patch |
A skin patch designed to reflect the naturally emitted infrared energy back into the body, with a reduced range of wavelength, intended to provide comfort and localized temporary relief of body aches and pains by phototherapeutic stimulation of strategic points on the skin. |
A |
| 49 |
Pain-relief static magnet |
A magnetized metal device designed to be worn on any part of the body (non-dedicated) and intended to produce a weak magnetic flux field over a superficial body site to provide comfort and localized temporary relief of body aches and pains. |
A |
| 50 |
Physical therapy paraffin wax bath |
A tub/enclosure, with an internal heating assembly, filled with liquid paraffin wax for physical therapy, to relieve pain and stiffness caused by arthritis or other joint inflammation, muscle spasms, or to help stimulate circulation. |
B |
| 51 |
Short-wave diathermy treatment system |
An assembly of devices designed to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands. The device is intended to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies. |
B |
| 52 |
Sitz bath |
A tub filled with water, that is heated by its heating elements and circulated by its agitators, intended for use in external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. |
A |
| 53 |
Sitz bath chair |
A device designed to be sat upon by a patient in a powered sitz bath for external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. |
A |
| 54 |
Static magnetic back/spine insulator |
A pad made of textile fabrics containing magnetic inserts and designed to be placed on the surface of the skin, on the back and/or part or the whole of the spine to help relieve medical ailments such as pain, muscle tension, poor blood circulation and to provide comfort by improving overall mobility. |
B |
| 55 |
Static magnetic bed mattress overlay |
A pad made of textile fabrics containing magnetic inserts intended to be placed on top of a bed mattress and contact an occupant’s body to help relieve medical ailments such as pain, muscle tension, poor blood circulation and to provide comfort by improving overall mobility. |
A |
| 56 |
Static magnetic belt |
A device, typically fashioned as a piece of clothing, containing or impregnated with a magnetized metal(s) or metallic compound(s), designed to be worn around the waist to produce a weak magnetic flux field that emanates from the waist to assist the whole body’s innate healing capability to alleviate body aches and pains. |
A |
| 57 |
Static magnetic bracelet |
A device, typically fashioned as a piece of jewellery, containing or impregnated with a magnetized metal(s) or metallic compound(s), designed to be worn around the wrist to produce a weak magnetic flux field that emanates from the surface of the wrist to assist the whole body’s innate healing capability to alleviate body aches and pains. |
A |
| 58 |
Static magnetic elbow orthosis |
A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the elbow joint to support the elbow and produce a weak magnetic flux field that emanates from the surface of the elbow to assist the whole body’s innate healing capability to alleviate body aches and pains. |
B |
| 59 |
Static magnetic foot arch orthosis |
A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn in a patient’s shoe, or other footwear, under the arch of the foot to support the arch and produce a weak magnetic flux field that emanates from the surface of the foot arch to assist the whole body’s innate healing capability to alleviate body aches and pains. |
B |
| 60 |
Static magnetic joint insulator |
A pad made of textile fabrics containing magnetic inserts and designed to be placed on the surface of the skin over/around a patient's hip or other limb joint to help relieve medical ailments such as pain, muscle tension, poor blood circulation and to provide comfort by improving overall mobility. |
B |
| 61 |
Static magnetic knee orthosis |
A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the knee joint to support the knee and produce a weak magnetic flux field that emanates from the surface of the knee to assist the whole body’s innate healing capability to alleviate body aches and pains. |
B |
| 62 |
Static magnetic lumbar spine orthosis |
A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the hips to support the lower back (spine and coccyx) and produce a weak magnetic flux field that emanates from the surface of the lower back to assist the whole body’s innate healing capability to alleviate body aches and pains. |
B |
| 63 |
Static magnetic massager |
A device designed to be moved over body surfaces that uses static magnets intended to produce a weak magnetic flux over a superficial body site to provide comfort and localized temporary relief from minor aches and pains. |
A |
| 64 |
Static magnetic shoulder orthosis |
A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the shoulder joint to support the shoulder and produce a weak magnetic flux field that emanates from the surface of the shoulder to assist the whole body’s innate healing capability to alleviate body aches and pains. |
B |
| 65 |
Static magnetic thoracic spine orthosis |
A body-support device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around the waist or across the shoulders to support the back (central- and upper spine) and produce a weak magnetic flux field that emanates from the surface of the central- and upper spine to assist the whole body’s innate healing capability to alleviate body aches and pains. |
B |
| 66 |
Traction system belt |
A harness designed to provide traction to the lower spine, including the lumbar and pelvic areas, with force from an external traction system. The harness is used mainly for relief of low back pain and to maintain normal alignment of the vertebrae. |
A |
| 67 |
Transcutaneous ElectroNeuro Stimulator (TENS) devices |
A therapy device intended to stimulate the nerves for pain relief. |
C |
| 68 |
Wearable cervical spine traction device |
An externally-worn orthopaedic device intended to apply traction to the cervical spine/neck to treat pain resulting from non-bone injuries/disorders. |
B |
| 69 |
Wearable lumbar spine traction device |
An externally-worn orthopaedic device designed to apply traction to the lumbar spine to relieve symptoms of back pain and sciatica. |
B |
| CATEGORY CARDIOVASCULAR |
|
|
|
| Sr No. |
Name Of Prouct(CardiovascularDiagnostic Devices) |
Intended Use/DeviceDescription |
Classification Ind MDR2017 First Schedule |
| 1 |
Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm) |
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. |
C |
| 2 |
Cardiac monitor (including cardiotachometer and rate alarm) |
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits. |
B |
| 3 |
Apex cardiograph (vibrocardiograph) |
An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer. |
B |
| 4 |
Echocardiograph |
An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. |
B |
| 5 |
Electrocardiograph |
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart. |
B |
| 6 |
Electrocardiograph electrode |
An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. |
C |
| 7 |
Vascular clip |
A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels. |
B |
| 8 |
Vena cava clip |
A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel. |
B |
| 9 |
Intra-aortic balloon and control system |
An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle. |
C |
| 10 |
Ventricular bypass (assist) device |
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body. |
D |
| 11 |
Pacing system analyzer |
A pacing system analyzer (PSA) is a prescription device that combines the functionality of a pacemaker electrode function tester and an external pacemaker pulse generator (EPPG). It is connected to a pacemaker lead and uses a power supply and electronic circuits to supply an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential. A PSA may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads. |
C |
| 12 |
Implantable pacemaker pulse generator |
An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body. |
D |
| 13 |
Pacemaker lead adaptor |
A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer. |
C |
| 14 |
Pacemaker generator function analyzer |
A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold. |
B |
| 15 |
Cardiovascular permanent or temporary pacemaker electrode |
A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. |
B |
| 16 |
Pacemaker test magnet |
A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation. |
A |
| 17 |
Pacemaker programmers |
A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker. |
D |
| 18 |
Pacemaker repair or replacement material |
A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator. |
D |
| 19 |
Pacemaker electrode function tester |
A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential. |
B |
| 20 |
Pacemaker service tools |
Pacemaker service tools are devices such as screwdrivers and Allen wrenches, used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker generator. |
A |
| 21 |
Annuloplasty ring |
An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency. |
C |
| 22 |
Carotid sinus nerve stimulator |
A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the carotid sinus. |
D |
| 23 |
Replacement heart valve |
A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials. |
D |
| 24 |
Endomyocardial biopsy device |
An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart. |
B |
| 25 |
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure |
An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors). |
C |
| 26 |
Cardiopulmonary bypass bubble detector |
A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit. |
B |
| 27 |
Cardiopulmonary bypass vascular catheter, cannula, or tubing |
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. |
B |
| 28 |
Cardiopulmonary bypass heart-lung machine console |
A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger. |
B |
| 29 |
Cardiopulmonary bypass defoamer |
A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood. |
C |
| 30 |
Cardiopulmonary bypass heat exchanger |
A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device. |
B |
| 31 |
Cardiopulmonary bypass temperature controller |
A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger. |
B |
| 32 |
Cardiopulmonary bypass arterial line blood filter |
A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line. |
C |
| 33 |
Cardiopulmonary bypass cardiotomy suction line blood filter |
A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line. |
B |
| 34 |
Cardiopulmonary bypass pulsatile flow generator |
A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator. |
D |
| 35 |
Intraluminal artery stripper |
An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arteriosclerotic arteries). |
B |
| 36 |
External cardiac compressor |
An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). |
C |
| 37 |
External transcutaneous cardiac pacemaker |
An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles. |
C |
| Sr No. |
Name Of Prouct |
Intended Use |
Classification India as per First schedule Part 1 MDR 2017 |
| 1 |
Agar dental impression material |
An impression material containing reversible agar hydrocolloid as a component for gelation. |
B |
| 2 |
Alginate dental impression material |
An impression material containing alginate as the primary component for gelation. |
B |
| 3 |
Dental collar/crown scissors |
Scissors used to cut delicate tissue, remove sutures, and perform precision procedures. |
A |
| 4 |
Dental excavator, reusable |
A device intended for cutting, cleaning out, and shaping a carious cavity before filling it. |
A |
| 5 |
Dental excavator, single-use |
A single-use device intended for cutting, cleaning out, and shaping a carious cavity before filling it. |
A |
| 6 |
Basic electric toothbrush, line-powered |
An electric toothbrush that uses electric power to move the brush head, normally in an oscillating pattern. |
A |
| 7 |
Basic manual toothbrush |
Intended for cleaning plaque from teeth and gums. |
A |
| 8 |
Composite dental impression material |
A thermoplastic impression material used to take an impression of the oral cavity. It is a mixture of natural resin, filler, and lubricant. |
B |
| 9 |
Dappen dish, reusable |
A small bowl used to mix and hold dental materials. These dishes can be disposable or reusable. |
A |
| 10 |
Dappen dish, single-use |
A small, shallow concave vessel used to knead and hold dental materials. |
A |
| 11 |
Dental examination kit |
Intended as kits for dental examination. |
A |
| 12 |
Dental crown, polymer |
A device made entirely of polymer-based material with or without fiber reinforcement, created for a specific patient, that functions as an artificial covering to replace the major part or the whole part of the clinical crown of a tooth. |
B |
| 13 |
Dental crown/bridge resin, temporary |
A material used to manufacture crowns and bridges temporarily. |
B |
| 14 |
Dental crown/bridge, temporary |
Intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. |
B |
| 15 |
Dental material mixing surface, reusable |
A dental instrument slab or tray used as a surface to mix dental materials. |
A |
| 16 |
Dental material mixing surface, single-use |
A pad or tray used to knead or mix dental material (impression material, cement, etc). |
A |
| 17 |
Dental spatula, reusable |
A dental instrument used to mix dental materials. Some are equipped with an injection function. |
A |
| 18 |
Dental spatula, single-use |
A spatula-shaped device used to knead or mix dental material (impression material, cement, etc). |
A |
| 19 |
Dental crown, metal/ceramic |
A device made of a combination of metal and tooth-colored ceramic, functioning as an artificial covering to replace the major part or the whole part of the clinical crown of a tooth. |
B |
| 20 |
Dental crown, metal/polymer |
A device made of metal, veneered with a polymer-based, tooth-colored material, created for a specific patient, functioning as an artificial covering to replace the major part or the whole part of the clinical crown of a tooth. |
B |
| 21 |
Wax dental impression material |
Used to take an oral impression. Made of wax, some materials are mixed with resin having a low melting point. |
A |
| 22 |
Dental impression material kit, reusable |
Devices and materials used to take the impression. |
A |
| 23 |
Dental impression material kit, single-use |
A collection of non-sterile devices designed to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and dental impression tray(s); This is a single-use device. |
A |
| 24 |
Dental impression material mixer |
An electric device used to mix impression materials immediately before use at the chair side. |
A |
| 25 |
Dental impression material syringe |
This dental injection syringe is used to inject the impression material onto the impression tray. |
A |
| 26 |
Dental impression tray material |
A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The material is used in cases in which a preformed impression tray is not suitable. |
A |
| 27 |
Dental impression tray, reusable |
An impression tray is a metal or plastic device intended to hold impression material, to make an impression of a patient's teeth to reproduce the structure of a patient's teeth. |
A |
| 28 |
Dental polishing brush |
A rotary dental brush intended for cleaning and polishing by a dental hygienist or a dentist. |
A |
| 29 |
Dental bone particle collector |
A device used to collect bone debris generated by drilling, etc. during oral surgery. |
B |
| 30 |
Dental bone matrix implant, animal-derived |
A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. |
C |
| 31 |
Dental suction system |
It evacuates solids, liquids, aerosols, and gases from the oral cavity and immediate surrounding area for the purpose of improving operating effectiveness and efficiency during oral treatment procedures and limiting the contamination of the immediate environment. |
B |
| 32 |
Dental suction system cannula, reusable |
A tubal dental device to be connected to a non-active aspiration device (usually, a dentistry dedicated device). Used to eliminate water and cutting debris that have accumulated in the oral cavity. This device is reusable after sterilization. |
A |
| 33 |
Dental suction system cannula, single-use |
A tubal dental device to be connected to a non-active aspiration device (usually, a dentistry dedicated device). Used to eliminate water and cutting debris that have accumulated in the oral cavity. |
A |
| 34 |
Carboxymethylcellulose sodium denture adhesive |
An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. |
C |
| 35 |
Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free |
An adhesive compound intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. |
C |
| 36 |
Dental amalgam |
A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). |
C |
| 37 |
Dental amalgam alloy |
A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. |
C |
| 38 |
Dental amalgam mercury |
Elemental mercury (Hg) of high purity intended for use as a component of dental amalgam in the restoration of a dental cavity or broken tooth. |
C |
| 39 |
Dental suction system fluid separation unit |
A separator used in the oral cavity. Used for the separation of fluids (saliva, blood) from gases to avoid liquids from entering the suction pump (i.e., dry suction). |
A |
| 40 |
Dental suction system pump |
An electrically-powered dental suction pump used as the suction source of a dental suction system, dental treatment unit, etc. |
B |
| 41 |
Plaster dental impression material |
This material is primarily made of calcium sulphate hemihydrate, and used to take an oral impression. |
A |
| 42 |
Polyether dental impression material |
An elastic material primarily made of polyether, which forms a rubber-like material suitable for taking impressions after reaction. |
B |
| 43 |
Polysulfide dental impression material |
An elastic material primarily made of polysulfide, which forms a rubber-like material suitable for taking impressions after reaction. |
B |
| 44 |
Silicone dental impression material |
An elastic material primarily made of polysiloxane, which forms a rubber-like material suitable for taking impression after reaction. |
B |
| 45 |
Temporary mandibular condyle prosthesis |
A sterile implantable device intended for the temporary reconstruction of the mandibular condyle of the temporomandibular joint (TMJ) typically in a patient undergoing ablative surgery requiring the removal of the mandibular condyle. |
C |
| 46 |
Temporomandibular joint disc |
A sterile interpositional implant or interarticular disc, intended to permanently interface between the natural mandibular condyle and natural glenoid fossa (mandibular fossa) in the temporomandibular joint (TMJ). |
C |
| 47 |
Assistive electric toothbrush |
It uses electric power to move the brush head, normally in an oscillating pattern. |
A |
| 48 |
Assistive manual toothbrush, reusable |
Used for cleaning plaque. |
A |
| 49 |
Assistive manual toothbrush, single-use |
Used for cleaning teeth and gum. |
A |
| 50 |
Bar dental precision attachment |
It connects removable partial dentures to fixed bridgework under a male/female locking mechanism. |
A |
| 51 |
Basic electric toothbrush, battery-powered |
A rotary dental brush used for cleaning teeth and gum by a person or a dental hygienist. |
A |
| 52 |
Dental suction system disinfection control unit |
An electrically-powered device intended to control the regular (typically daily) automated/semi-automated disinfection of a dental suction system tubing line. |
B |
| 53 |
Transgingival implant |
A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis. |
C |
| 54 |
Zinc polycarboxylate dental cement |
A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). |
B |
| 55 |
Transmandibular implant |
A sterile transosteal (transosseous) device [transmandibular implant (TMI)] intended to be surgically implanted through mandibular bone to provide support and a means of retention for a dental prosthesis, especially in a patient with an extremely atrophied/deformed mandible. |
C |
| 56 |
Pliable-polymer dental regeneration membrane, bioabsorbable, ligated |
A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the downgrowth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. |
C |
| 57 |
Pliable-polymer dental regeneration membrane, bioabsorbable, tacked |
A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the downgrowth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. |
C |
| 58 |
Dental surgical procedure kit, medicated, reusable |
A collection of various dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure. |
C |
| 59 |
Dental surgical procedure kit, medicated, single-use |
A collection of various sterile dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure. |
C |
| 60 |
Membrane fixation tack, bioabsorbable |
A sterile bioabsorbable tack intended to be used to fix a pliable-polymer dental regeneration membrane in situ to aid in the regeneration of tooth support that has been lost due to periodontal disease or trauma. |
C |
| 61 |
Periodontal root surface regeneration material |
A bioabsorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support. |
C |
| 62 |
Periodontal tissue reconstructive material |
A sterile viscous material intended to be injected into the buccal mucosa to treat deficiencies of the gingiva (e.g., interdental papillae), through augmentation, during the treatment of intermediate stage periodontal disease. |
C |
| 63 |
Bone matrix implant, human-derived |
A sterile implantable device made primarily of human demineralized bone matrix (DBM) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. |
C |
| 64 |
Collagen dental regeneration membrane |
A sterile, bioabsorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and/or to regenerate bone or bone defects around dental implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. |
C |
| 65 |
Dental cotton roll |
It is intended as an absorbent, hard-packed cylinder (a roll) that is used as a saliva absorber from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. |
A |
| 66 |
Dental impression tray, single-use |
The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device. |
A |
| 67 |
Preformed dental crown, permanent |
A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure. |
B |
| 68 |
Preformed dental crown, temporary |
This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury. |
B |
| 69 |
Zinc phosphate dental cement |
A non-sterile substance intended for professional use as a dental cement and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. |
B |
| 70 |
Dental articulation paper forceps |
A hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patient's oral cavity. |
A |
| 71 |
Dental dressing forceps, reusable |
A hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. |
A |
| 72 |
Dental dressing forceps, single-use |
A sterile, hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. |
A |
| 73 |
Rubber dam clamp forceps |
A hand-held dental instrument used for the insertion and removal of rubber dam clamps. |
A |
| 74 |
Tooth extraction forceps |
A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. |
A |
| 75 |
Dental amalgam capsule |
A small container in which silver (Ag) alloy is intended to be mixed with mercury (Hg) to form dental amalgam. |
A |
| 76 |
Dental amalgam mercury dispenser |
A device with a valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form which is to be used to produce amalgam filling material. |
A |
| 77 |
Dental anaesthesia injection kit |
A collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. |
B |
| 78 |
Dental anaesthesia syringe cartridge |
A plastic or glass container prefilled with a single dose of anaesthetic medication intended to be inserted into a dental anaesthesia syringe and injected into oral tissues for a dental procedure. |
B |
| 79 |
Dental anaesthesia syringe, intraligamentary |
A hand-held manual dental instrument intended to be used to inject an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device. |
A |
| 80 |
Dental anaesthesia syringe, reusable |
A hand-held manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. |
A |
| 81 |
Dental anaesthesia syringe, single-use |
A sterile, hand-held, manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle (needle not included). |
A |
| 82 |
Dental anaesthesia syringe/needle |
A hand-held manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an included sterile needle; the needle may be attached or detached. |
A |
| 83 |
Dental anaesthesia system |
An assembly of devices used for the administration of a proportional mixture of oxygen (O2) and nitrous oxide (N2O) or medical air during dental surgical treatment. |
C |
| 84 |
Bite registration rim |
A schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships. |
B |
| 85 |
Bite registration rim wax |
A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device. |
B |
| 86 |
Bite registration rim wax, plate |
A dental material (modelling wax) delivered as prefabricated plates of wax with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). |
B |
| 87 |
Calcium hydroxide dental cement |
Use as a dental cement and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid. |
C |
| 88 |
Ceramic artificial teeth |
Prefabricated teeth made of ceramic (porcelain) for mounting on removable dentures or fixed partial dentures. |
B |
| 89 |
Dental soft-tissue matrix implant, animal-derived |
A sterile, bioabsorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device. |
C |
| CATEGORY : ENT |
|
|
|
| Sr No. |
MEDICAL DEVICE NAME |
INTEND USE |
INDIA |
| 1 |
Adenotome |
Surgical instrument intended to dissect the adenoids. |
A |
| 2 |
Adenotome blade |
Intended to mount on adenotome and perform dissection of adenoids. |
B |
| 3 |
Anchored bone-conduction hearing implant system |
Intended to treat hearing impairment due to middle and/or outer ear obstructive pathologies or types of conductive hearing loss. |
C |
| 4 |
Audiometer testing system |
An assembly of electronic reference devices intended to calibrate an audiometer. |
A |
| 5 |
Audiometer |
Intended for evaluation of hearing by generating tones throughout the audible range. |
B |
| 6 |
Otoscope |
Intended for visual examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. |
B |
| 7 |
Auditory evoked-potential graphic recorder |
Intended to record an electrical potential that originates in the auditory pathway of the brain in response to acoustic stimuli. |
B |
| 8 |
Auditory stimulator |
Intended to apply sound stimuli to a patient's acoustic system. |
C |
| 9 |
Behind-the-ear air-conduction hearing aid |
Intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. |
B |
| 10 |
Behind-the-ear air-conduction tinnitus masker |
Intended to provide noise of sufficient intensity and bandwidth to mask tinnitus. |
B |
| 11 |
Behind-the-ear boneconduction tinnitus masker |
Intended to provide ultrasonic broadband noise and/or sweep-frequency stimuli noise of sufficient intensity and bandwidth to mask tinnitus. |
C |
| 12 |
Cochlear implant assessment system |
Intended to perform an integrity test on the implantable portion of a cochlear implant (CI) system insitu. |
C |
| 13 |
Ear bowl |
Constructed to fit the curvature of the head so that it will sit closely under the ear lobe and enable treatments of ear. |
A |
| 14 |
Ear canal impression tray |
Intended to hold and confine the impression material in opposition to the surfaces to be recorded, and to control the impression material while it sets to form the impression of the ear canal. |
A |
| 15 |
Ear canal light |
Intended to illuminate the ear canal. |
A |
| 16 |
Ear excavator |
Designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear. |
A |
| 17 |
Ear prosthesis |
Intended to reconstruct the external ear by replacing damaged or missing tissue. |
C |
| 18 |
Ear wick |
Intended to minimize bleeding during ear surgery. |
B |
| 19 |
Electroglottograph |
Intended for recording the changes in electrical potential or impedance, resulting from movement of the vocal cords during respiration and phonation. |
B |
| 20 |
Endaural curette |
Designed for scraping within the ear canal (e.g., removing wax), and for procedures during middle ear surgery (e.g., removal of the superior bony rim). |
A |
| 21 |
ENT chair, electric |
Designed to support a patient in a seated position, electrically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. |
B |
| 22 |
ENT chair, mechanical |
Designed to support a patient in a seated position, mechanically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. |
B |
| 23 |
ENT shaver system |
Intended to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). |
B |
| 24 |
ENT surgical microscope |
Intended to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing. |
B |
| 25 |
ENT transilluminator |
Intended to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination. |
A |
| 26 |
Evoked-potential audiometer |
Electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] in patients. |
B |
| 27 |
Flexible fibreoptic nasopharyngolaryngoscope |
Flexible endoscope intended for the visual examination and treatment of the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. |
B |
| 28 |
Flexible fibreoptic nasopharyngoscope |
Flexible endoscope intended for the visual examination and treatment of nasopharynx (the upper part of the throat behind the nose). |
B |
| 29 |
Flexible fibreoptic rhinoscope |
Flexible endoscope intended for the visual examination and treatment of nasal cavity. |
B |
| 30 |
Flexible fibreoptic sinoscope |
Flexible endoscope intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. |
B |
| 31 |
Flexible video antroscope |
Flexible endoscope intended for the visual examination and treatment of a cavity, particularly the pathological changes in the area of the maxillary sinus. |
B |
| 32 |
Impedance audiometer |
Intended to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. |
B |
| 33 |
Nasal septum straightening forceps |
Surgical instrument specifically designed to straighten the nasal septum through grasping and manipulation of the bone/cartilage of the septum during nasal reconstructive procedures. |
A |
| 34 |
ENT Nasal snare |
A hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. |
B |
| 35 |
Ossicular prosthesis, partial |
Intended to be implanted for the functional reconstruction of segments of the ossicular chain (malleus, incus, and/or stapes bones). |
C |
| 36 |
Otoscope, endoscopic |
Intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. |
B |
| 37 |
Tonsil knife |
Intended for the removal of the tonsils during a surgical intervention. |
A |
| 38 |
Tracheal bistoury |
Designed for opening abscesses or slitting up sinuses and/or fistulas in the trachea. |
A |
| 39 |
Middle ear mold |
A preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. |
C |
| 40 |
Fully-implantable middle ear implant system |
An implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device. |
C |
| 41 |
Larynx prosthesis |
A device used for replacement and restoration of the laryngeal function, or for maintenance of patency of the larynx. |
C |
| 42 |
Ossicular prosthesis, total |
A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (malleus, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. |
C |
| 43 |
Otoscope, direct |
Intended for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. |
B |
| 44 |
Soft-tissue surgical forceps, alligator |
A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]. |
B |
| 45 |
Epistaxis balloon |
Device intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery. |
B |
| 46 |
Eustachian tube balloon dilation system |
The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction. |
B |
| 47 |
Ear, nose, and throat electric or pneumatic surgical drill |
An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur, for the controlled incision or removal of bone in the ear, nose, and throat area. |
C |
| 48 |
Argon laser for otology, rhinology, and laryngology |
Device used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue while performing ENT surgical procedure. |
C |
| 49 |
Ear, nose, and throat microsurgical carbon dioxide laser |
Device intended for the surgical excision of tissue from the ear, nose, and throat area while performing microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas. |
C |
| 50 |
Esophagoscope (flexible or rigid) |
Device intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. |
B |
| 51 |
Mediastinoscope and accessories |
Device intended to examine or treat tissue in the area separating the lungs for diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. |
B |
| 52 |
Laryngostroboscope |
A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. |
B |
| 53 |
Bone particle collector |
A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. |
A |
| 54 |
Suction antichoke device |
A suction antichoke device is a device intended to be used in an emergency situation to remove, by the application of suction, foreign objects that obstruct a patient's airway to prevent asphyxiation to the patient. |
C |
| 55 |
Tongs antichoke device |
A tongs antichoke device is a device that is intended to be used in an emergency situation to grasp and remove foreign objects that obstruct a patient's airway to prevent asphyxiation of the patient. |
C |
| 56 |
Powered nasal irrigator |
A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. |
B |
| 57 |
External nasal splint |
An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose. |
A |
| 58 |
Antistammering device |
An antistammering device intended to minimize a user's involuntary hesitative or repetitive speech. |
B |
| 59 |
External upper esophageal sphincter compression device |
An external upper esophageal sphincter compression device is intended to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease. |
C |
| 60 |
Wireless air-conduction hearing aid |
A wireless air-conduction hearing aid is intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. |
B |
| 61 |
Hearing aid calibrator and analysis system |
A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. |
B |
| 62 |
Tympanic membrane contact hearing aid |
A tympanic membrane contact hearing aid is a prescription device that compensates for impaired hearing by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane. |
D |
| 63 |
Master hearing aid |
A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. |
B |
| 64 |
Active implantable bone conduction hearing system |
The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. |
C |
| 65 |
Battery-powered artificial larynx |
A battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. |
B |
| 66 |
Partial ossicular replacement prosthesis |
A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. |
C |
| 67 |
Total ossicular replacement prosthesis |
A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. |
C |
| 68 |
Mandibular implant facial prosthesis |
A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of mandibular deficits. |
C |
| 69 |
Sacculotomy tack (Cody tack) |
A sacculotomy tack (Cody tack) is a device that consists of a pointed stainless steel tack intended to be implanted to relieve the symptoms of vertigo. |
C |
| 70 |
Nasal dilator |
A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. |
B |
| 71 |
Tympanostomy tube with semipermeable membrane |
A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for ventilation or drainage of the middle ear and for preventing fluids from entering the middle ear cavity. |
C |
| 72 |
Transcutaneous air conduction hearing aid system |
A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. |
C |
| 73 |
Acoustic chamber for audiometric testing |
An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds. |
A |
| 74 |
Gustometer |
A gustometer is a battery-powered device that consists of two electrodes that are intended to provide galvanic stimulus resulting in taste sensation. |
C |
| 75 |
ENT cupped forceps |
A forcep with a spoon-(dish) like configuration at the distal end, and is used to treat the ear, nose, and throat (ENT), and remove tissue from the body. |
A |
| 76 |
Tongue depressor |
A surgical instrument used to move the tongue to facilitate examination of surrounding organs and tissue. |
A |
| 77 |
Tracheal dilator |
Intended to dilate the tracheal structure and tracheal passageway. |
A |
| 78 |
Tonsillectome |
A manually operated surgical device used to dissect the tonsils. |
A |
| Category: Gastroenterology |
|
|
|
| Sr No. |
Name Of Prouct |
Intended Use |
Classification India as per First schedule Part 1 MDR 2017 |
| 1 |
Absorbent enteric stomal dressing |
To be placed over a continent enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained from the intestines) to protect it from harmful external influences, which includes absorbent materials intended to protect the surrounding skin from enteric fluids. |
B |
| 2 |
Anal fistula circular cutter |
To be intended for the circumferential resection of tissue to treat simple anal fistula |
B |
| 3 |
Anal fistula seton |
A sterile implantable cord intended to be placed through an anal fistula tract and tied outside the fistula, forming a loop around the anus, to allow drainage through the fistula for tissue healing. |
C |
| 4 |
Anoscope, reusable |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. |
B |
| 5 |
Anoscope, single-use |
A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. |
B |
| 6 |
Barium enema catheter |
A flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area. |
B |
| 7 |
Bile duct prosthesis |
An implantable artificial substitute for the tube-like structure that carries bile from the gallbladder to the duodenum. |
C |
| 8 |
Biliary drainage catheter |
A flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. |
C |
| 9 |
Biliary manometric catheter |
A sterile, non-electrical flexible tube intended to be inserted into the biliary tree to measure pressures within the ducts, especially to evaluate sphincter of Oddi function. |
B |
| 10 |
Catheter-balloon inflator, reprocessed |
A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure.It is typically used during angiography, angioplasty, gastrointestinal (GI), or sinuplasty procedures. |
B |
| 11 |
Catheter-balloon inflator, reusable |
A device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. |
B |
| 12 |
Catheter-balloon inflator, single-use |
A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. |
B |
| 13 |
Cholangiopancreatography catheter, reusable |
A flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). |
B |
| 14 |
Cholangiopancreatography catheter, single-use |
A flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, intended for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). |
B |
| 15 |
Closed-ended intestinal ostomy bag, multiple-piece |
A non-sterile plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. |
A |
| 16 |
Closed-ended intestinal ostomy bag, one-piece |
A non-sterile plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. |
A |
| 17 |
Colonic endoscopy cuff |
A sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. |
B |
| 18 |
Colonic lavage kit, surgical |
A collection of sterile devices intended to be used during open colorectal surgery (bowel resection) to irrigate the colon above (proximal to) the site of a lesion/blockage, prior to surgical anastomosis, when preoperative preparation of the colon has not been possible, normally due to obstruction. |
B |
| 19 |
Colonic mucosa barrier dressing |
A non-sterile solution/suspension intended to be introduced into the sigmoid/descending colon as an enema for the treatment of inflammatory bowel disease (e.g., ulcerative colitis). It is intended to create an adhesive physical barrier on the colonic mucosa to protect the mucosa from potentially harmful substances in the distal colon lumen. |
C |
| 20 |
Colonoscope positioning sleeve |
A non-sterile endoscopic sheath with two inflatable balloons designed to be mounted on a colonoscope to position and stabilize the endoscope within the large intestine of a patient. |
B |
| 21 |
Colonoscope stiffener |
A dedicated stiff wire that is inserted into a flexible colonoscope to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required during a colonoscopy. |
B |
| 22 |
Colorectal sizer |
A hand-held manual surgical instrument designed to assess colon and/or rectal lumen diameter to aid the selection of an appropriate size intraluminal stapler (i.e., the stapler head) for bowel anastomosis following transection. |
B |
| 23 |
Common bile duct dilator |
A hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts. |
B |
| 24 |
Duodenal bypass liner |
A non-sterile stent-like device with a valve designed to be implanted in the duodenum where it is intended to reduce duodenal nutrient absorption from food to facilitate obese patient weight loss. |
C |
| 25 |
Duodenal-jejunal bypass liner |
A sterile stent-like implant designed to function as an impermeable barrier in the duodenum and part of the jejunum for partially-digested food from the stomach (chyme) passing on its inside and bile/digestive enzymes passing on its outside, intended to treat type 2 diabetes mellitus and obesity. |
C |
| 26 |
Endoscope tissue removal cap |
A sterile plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue during electrosurgical treatment (e.g., for the treatment of Barrett’s oesophagus). |
B |
| 27 |
Endoscopic biopsy valve, non-sterile |
A non-sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. |
B |
| 28 |
Endoscopic biopsy valve, sterile |
A sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. |
B |
| 29 |
Endoscopic cutting stapler connector |
A rod-like component of an endoscopic cutting stapler intended to enable connection between the stapler handpiece and the endpiece/loading unit. |
B |
| 30 |
Endoscopic electrosurgical biopsy/resection kit, full-thickness |
A collection of sterile devices, which includes an implantable haemostatic ligation clip, intended to be used to obtain a full-thickness tissue biopsy and/or therapeutic resection of gastric, duodenal, colonic, and/or rectal tissue during an endoscopic procedure. |
B |
| 31 |
Endoscopic electrosurgical biopsy/resection kit, partial-thickness |
A collection of devices designed to be inserted through a compatible endoscope to obtain a mucosal tissue biopsy and/or therapeutic resection of upper gastrointestinal (GI) tract tissue, typically during endoscopic retrograde cholangiopancreatography (ERCP) procedures. |
B |
| 32 |
Endoscopic electrosurgical electrode/submucosal lift needle |
A sterile, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) an electrosurgical current in a monopolar configuration (i.e., with a return electrode) to tissues for cutting/coagulation. |
B |
| 33 |
Endoscopic gastrointestinal stenosis dilator |
A sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization. |
B |
| 34 |
Endoscopic motorized cutting stapler, reusable |
A hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses. |
B |
| 35 |
Endoscopic motorized cutting stapler, single-use |
A sterile, hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses. |
B |
| 36 |
Endoscopic needleless submucosal lift catheter |
A sterile, flexible tube intended to non-invasively deliver a submucosal lifting solution into the submucosa of the gastrointestinal tract through a flexible endoscope during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision. |
B |
| 37 |
Endoscopic overtube, reusable |
A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). |
B |
| 38 |
Endoscopic spray catheter |
A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal coloration) in spray form. |
B |
| 39 |
Enema tip, reusable |
A non-sterile device made with Hevea natural rubber latex (NRL) intended to be connected to an enema tube to facilitate delivery of an enema solution into the rectum. |
A |
| 40 |
Enema tube |
A non-sterile, length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum. |
A |
| 41 |
Enteral feeding kit, adult/paediatric, non-sterile |
A collection of non-sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. |
C |
| 42 |
Enteral feeding kit, adult/paediatric, sterile |
A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. |
C |
| 43 |
Enteral feeding tube clearing kit |
A collection of non-sterile compounds and devices intended to be used to prevent and/or remove, through biochemical action, an enteral formula clog in an in situ enteral feeding tube to maintain luminal patency. |
C |
| 44 |
Enteral feeding/decompression tube clearing stem |
A non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency. |
A |
| 45 |
Enteral tube extension, non-sterile |
A non-sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. |
A |
| 46 |
Enteral tube extension, sterile |
A sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. |
A |
| 47 |
Externally-propelled flexible video colonoscope |
A non-sterile endoscope with a highly flexible sleeve and distal tip intended for the visual examination of the entire adult colon [lower gastrointestinal (GI) tract]. |
B |
| 48 |
Fistula-repair biomatrix implant |
A sterile, bioabsorbable, animal-derived substance intended to be injected into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue. |
D |
| 49 |
Flexible fibreoptic choledochoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). |
B |
| 50 |
Flexible fibreoptic colonoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. |
B |
| 51 |
Flexible fibreoptic duodenoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). |
B |
| 52 |
Flexible fibreoptic enteroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). |
B |
| 53 |
Flexible fibreoptic gastroduodenoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. |
B |
| 54 |
Flexible fibreoptic gastroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. |
B |
| 55 |
Flexible fibreoptic oesophagoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. |
B |
| 56 |
Flexible fibreoptic pancreatoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas. |
B |
| 57 |
Flexible fibreoptic sigmoidoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). |
B |
| 58 |
Flexible ultrasound colonoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. |
B |
| 59 |
Flexible ultrasound duodenoscope |
An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the duodenum (the first part of the small intestine). |
B |
| 60 |
Flexible ultrasound gastroduodenoscope |
An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. |
B |
| 61 |
Flexible video choledochoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). |
B |
| 62 |
Flexible video choledochoscope, single-use |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. |
B |
| 63 |
Flexible video colonoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. |
B |
| 64 |
Flexible video colonoscope, single-use |
A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. |
B |
| 65 |
Flexible video duodenoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). |
B |
| 66 |
Flexible video duodenoscope, single-use |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). |
B |
| 67 |
Flexible video enteroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). |
B |
| 68 |
Flexible video gastroduodenoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. |
B |
| 69 |
Flexible video gastroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. |
B |
| 70 |
Flexible video oesophagoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device. |
B |
| 71 |
Flexible video oesophagoscope, single-use |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. |
B |
| 72 |
Flexible video pancreatoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas. |
B |
| 73 |
Flexible video sigmoidoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). |
B |
| 74 |
Gastric sleeve |
A sterile implantable device intended to be wrapped around the proximal portion of the stomach to reduce stomach volume and facilitate weight loss in overweight/obese patients by attempting to restrict the quantity of food consumed through an increased sense of satiety (fullness). |
C |
| 75 |
Gastric tonometry catheter |
A sterile flexible tube intended for orogastric, nasogastric, or rectal insertion to sample carbon dioxide (CO2) from the mucosal vasculature of the stomach or sigmoid colon for the measurement of partial pressure (i.e., tonometry) of CO2 (pCO2) during diagnosis of mesenteric ischemia. |
B |
| 76 |
Gastrointestinal anastomosis coupler, bioabsorbable |
An implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached. |
D |
| 77 |
Gastrointestinal anastomosis coupler, non-bioabsorbable |
An implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached. |
C |
| 78 |
Gastrointestinal catheter/endoscope tracking system |
A multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying three-dimensional (3-D) virtual images on a monitoring screen. |
B |
| 79 |
Gastrointestinal endoscopic clip applier |
A device intended to be used in combination with a compatible flexible endoscope for the application of gastrointestinal endoscopic clip(s) [not included] to the mucosal lining of the gastrointestinal (GI) tract for endoscopic marking, hemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects during an endoscopic procedure. |
B |
| 80 |
Gastrointestinal endoscopic clip cutter |
A sterile device intended to be used in combination with a generator to remove a gastrointestinal endoscopic clip. |
B |
| 81 |
Gastrointestinal endoscopic clip cutter generator |
A portable, mains electricity (AC-powered) device intended to be used in conjunction with a cutter for the endoscopic removal of a gastrointestinal endoscopic clip. |
B |
| 82 |
Gastrointestinal endoscopic clip, long-term |
A sterile clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. |
C |
| 83 |
Gastrointestinal endoscopic clip, short-term |
A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. |
C |
| 84 |
Gastrointestinal manometric catheter, electronic |
A non-sterile flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen. |
B |
| 85 |
Gastrointestinal manometric catheter, non-electronic |
A non-sterile, non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. |
B |
| 86 |
Gastrointestinal ostomy tube pocket |
A non-sterile, noninvasive pouch designed to be wrapped around the protruding end of a gastrointestinal ostomy tube (e.g., gastrostomy or jejunostomy tube) to hold and support it in order to ensure its stabilization on the patient. |
A |
| 87 |
Gastrointestinal/airway foreign body retrieval basket |
A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). |
B |
| 88 |
Gastrojejunostomy tube |
A sterile, thin, flexible, hollow cylinder percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods, with an extended portion inserted through the pylorus into the jejunum. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. |
C |
| 89 |
Gastro-oesophageal antireflux prosthesis |
An implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. |
C |
| 90 |
Gastro-oesophageal pH/impedance catheter, non-sterile |
A non-sterile flexible tube with electronic sensors at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions. |
B |
| 91 |
Gastro-oesophageal pH/impedance catheter, sterile |
A sterile flexible tube with an with an electrical conductor at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions. |
B |
| 92 |
Gastrostomy aspiration system gravity set |
A collection of non-sterile devices designed as the external portion of a gastrostomy aspiration system intended to be used post-surgery by the patient after implantation of the stomach tube for the removal of a portion of stomach contents after meals, by aspiration, to achieve portion control and subsequently weight loss in a morbidly obese (bariatric) patient (≥ 18 years). |
C |
| 93 |
Gastrostomy aspiration system stomach tube |
A sterile, thin, flexible, hollow cylinder intended to be percutaneously implanted by endoscopic methods into the stomach of a morbidly obese (bariatric) patient (≥ 18 years) for the removal of a portion of stomach contents after meals by aspiration when used with a dedicated gravity kit that is the external portion of a gastrostomy aspiration system. |
C |
| 94 |
Gastrostomy button |
A sterile, short, tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. |
C |
| 95 |
Gastrostomy T fastener |
A device intended to be inserted into the stomach percutaneously to appose the anterior gastric wall to the anterior abdominal wall, typically to facilitate the insertion of a percutaneous gastrostomy tube or for procedures requiring stabilization/fixation of hollow gastrointestinal (GI) structures. |
C |
| 96 |
Gastrostomy tube |
A sterile, thin, flexible, hollow cylinder percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. |
C |
| 97 |
Gastrostomy tube Y-piece connector |
A sterile connecting device shaped in the form of a "Y" intended for connection to the proximal end of a gastrostomy tube to enable administration of nutrient liquids and/or medication through the gastrostomy tube. |
B |
| 98 |
Gastro-urological director |
A slender, rod-like surgical instrument made of metal, typically with groove running along the centre of its distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. |
B |
| 99 |
Gastro-urological probe |
A slender, rod-like, hand-held manual surgical instrument, typically made of flexible metal with a blunt bulbous tip, designed for exploring gastroenterological/urological (GU) structures during a GU procedure. |
B |
| 100 |
Gastro-urological scoop |
A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long thin shaft that is used to access and scrape tissue from the common hepatic/bile duct system during a gastroenterological/urological (GU) procedure. |
B |
| 101 |
Gravity enema set |
A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. |
A |
| 102 |
Implantable gastric clamp |
A sterile implantable device designed to isolate the lesser curvature segment of the stomach (magenstrasse) to reduce stomach volume and facilitate weight loss in overweight/obese patients through a reduction in food consumption based on an increased sense of satiety (fullness). |
C |
| 103 |
Implantable incontinence-control electrical stimulation system |
An assembly of battery-powered devices intended to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence, through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. |
C |
| 104 |
Implantable peritoneal catheter holder |
A small, sterile, implantable device designed to secure a peritoneal or lumboperitoneal catheter in situ by suturing it to the abdominal fascia at the point of entry/exit. |
C |
| 105 |
Intestinal ostomy bag anti-adhesion device |
A non-sterile, noninvasive device intended to be applied to the inner surface of an intestinal ostomy bag to prevent opposing inner walls of the bag from sticking together (anti-pancaking). |
A |
| 106 |
Intestinal ostomy kit |
A collection of non-sterile devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). |
A |
| 107 |
Intestinal splint |
A sterile rigid or flexible device intended to be implanted within the abdomen to stabilize a portion of the intestine, or to stabilize and protect an injured portion of the intestine. |
C |
| 108 |
Intestinal stoma shield/support belt, reusable |
A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. |
B |
| 109 |
Intestinal stoma shield/support belt, single-use |
A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. |
B |
| 110 |
Intraluminal oesophageal retractor |
A sterile, hand-held manual surgical instrument intended to be inserted through an orogastric (or nasogastric) tube to mechanically divert the oesophagus away from the site of surgery during electrical treatments of the heart (e.g., cardiac ablation), to facilitate surgical site access and to help prevent injury to the oesophagus. |
B |
| 111 |
Invasive silicone sheet dressing |
A sterile, flat stretch of silicone elastomer intended for use as a short-term intra-abdominal dressing following abdominal surgery, when a re-exploration of the wound/abdomen is planned within a thirty day period. It is used to achieve temporary abdominal closure to avoid the complications of an open abdomen. |
B |
| 112 |
Jejunostomy tube |
A sterile, thin, flexible, hollow cylinder percutaneously inserted into the jejunum, typically through puncture of the abdominal wall and stomach after distention of the gut by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. |
C |
| 113 |
Laparoscopic cholangiography catheter/needle |
A sterile, flexible, single-lumen tube with a distal needle intended to puncture the neck of the gallbladder (Hartmann’s pouch) during laparoscopic cholangiography to allow injection of contrast media. |
B |
| 114 |
Laparoscopic grasping forceps, reprocessed |
A sterile, rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. |
B |
| 115 |
Laparoscopic grasping forceps, reusable |
A rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. |
B |
| 116 |
Laparoscopic grasping forceps, single-use |
A sterile, rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. |
B |
| 117 |
Laparoscopic swab forceps |
An instrument designed to grasp a pledget swab at the distal end to obtain cytological specimens and/or to perform blunt dissection during gynaecologic and/or other (e.g., cholecystectomy) laparoscopic procedures. |
B |
| 118 |
Manual enema device |
A non-sterile device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis. |
B |
| 119 |
Manual enema device, reusable |
A device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis. |
B |
| 120 |
Manual rectal irrigation system |
A portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. |
B |
| 121 |
Motorized laparoscopic forceps |
A mains electricity (AC-powered) motorized surgical instrument designed for grasping, mobilizing, and suturing tissues/vessels under direct or endoscopic visualization during a surgical procedure. |
B |
| 122 |
Nasoenteral tube |
A sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. |
C |
| 123 |
Nasogastric decompression tube |
A sterile, thin, flexible, hollow, single- or double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily to reduce the pressure within the gastrointestinal tract, typically aided by connection to an intermittent suction system, that may follow presurgical or postsurgical intestinal occlusion. |
B |
| 124 |
Nasogastric tube holder, intranasal |
A non-sterile, non-surgically invasive device intended to be used to secure a nasogastric tube to the nose of a patient to prevent displacement or removal of the tube. |
B |
| 125 |
Nasogastric tube holder, noninvasive, non-sterile |
A small, non-sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. |
A |
| 126 |
Nasogastric tube holder, noninvasive, sterile |
A small, sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. |
A |
| 127 |
Non-vascular catheter introduction set |
A collection of sterile, invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter). |
C |
| 128 |
Oesophageal temperature monitor |
An electronic device used to monitor the temperature of the oesophagus during surgical ablation of the wall of the left atrium. It typically measures the oesophageal temperature at several adjacent levels, and displays these temperature values simultaneously to help the surgeon avoid the application of heat high enough to form atrial-oesophageal fistulas. |
B |
| 129 |
Oesophageal tube |
A sterile, hollow cylinder that usually contains two balloons, one for the stomach and one for the oesophagus, which are inflated after the device has been inserted into the oesophagus to tampon bleeding oesophageal varices. |
C |
| 130 |
Over-guidewire oesophageal dilator |
A surgical instrument in the form of a slender, hollow cylinder made of metal, plastic or other suitable material, designed to dilate oesophageal strictures/passages after being passed over a pre-positioned guidewire, typically in sequentially increasing sizes. It is commonly used prior to and to assist in a gastroscopy and is available in a variety of sizes and flexibilities. |
B |
| 131 |
Paediatric-temperature nasogastric/orogastric tube |
A sterile, thin, flexible, hollow cylinder designed as a paediatric or neonatal enteral feeding tube with an integrated temperature sensor that continuously measures oesophageal temperature. |
C |
| 132 |
Partially-implantable abdominal port/catheter |
A sterile partially-implantable device intended to provide access to the peritoneal cavity for infusion (e.g., insulin, chemotherapeutic agents). |
C |
| 133 |
Percutaneous biliary biopsy procedure kit |
A collection of sterile devices intended to be used to obtain a tissue specimen from within the biliary duct system for histological analysis by a percutaneous approach, typically under fluoroscopic visualization. |
B |
| 134 |
Pharyngeal electrical stimulation catheter |
A sterile, flexible tubular device intended to deliver pharyngeal electrical stimulation for the treatment of neurogenic dysphagia. |
C |
| 135 |
Powered rectal/colostomy irrigation system |
A portable assembly of battery-powered devices intended to be used by, or on a patient, for the controlled introduction of a non-medicated solution (typically water) into the rectum to treat faecal incontinence or constipation (rectal irrigation), and/or for colostomy site irrigation. |
B |
| 136 |
Probiotic oropharyngeal mucosa dressing |
A non-sterile substance intended to be applied to the mucosa of the mouth and/or pharynx to facilitate saprophytic microflora colonization within the oral cavity/pharynx, typically following antibiotic therapy, bacterial infection, or injury. It includes probiotic bacteria (e.g., Streptococcus salivarius, Streptococcus oralis) and compounds that create a barrier to facilitate growth of the probiotic bacteria. |
C |
| 137 |
Proctoscope, reusable |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. |
B |
| 138 |
Proctoscope, single-use |
A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. |
B |
| 139 |
Rectal irrigation kit |
A collection of non-sterile devices intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation. |
B |
| 140 |
Rectal speculum |
A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. |
B |
| 141 |
Rectal suction biopsy system |
An assembly of disposable and reusable devices designed to obtain a submucosal tissue specimen from the rectum using suction [rectal suction biopsy (RSB)], typically for histopathological analysis [e.g., to help diagnose Hirschsprung's disease (HD)]. |
B |
| 142 |
Rectal/colonic lavage support kit |
A collection of non-sterile, noninvasive devices intended to be used in conjunction with a rectal and/or colonic irrigation system to support the introduction of an irrigation solution into the rectum/colon. |
A |
| 143 |
Rectoscope, reusable |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. |
B |
| 144 |
Rectoscope, single-use |
A sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. |
B |
| 145 |
Rectoscope/proctoscope handle |
A manual device intended to be used as a handle to hold a rectoscope or proctoscope during an examination procedure. |
A |
| 146 |
Rectosocope/proctoscope handle end-cap |
A small cap intended to be fitted to the proximal end of the handle of a rectoscope or proctoscope during an examination procedure to provide an airtight seal so that air can be pumped through the scope to inflate the bowel. |
A |
| 147 |
Rigid oesophagoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus. |
B |
| 148 |
Rigid sigmoidoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). |
B |
| 149 |
Robotic electrosurgical instrument, bipolar, single-use |
A sterile electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. |
C |
| 150 |
Robotic surgical retractor |
A surgical device intended to be used in conjunction with a robotic surgical system to enable retraction of tissues during a robotic endoscopic procedure. |
B |
| 151 |
Self-propelled flexible video colonoscope |
A sterile endoscope with a highly-flexible, self-propelled, inserted portion intended for the visual examination of the entire colon. |
B |
| 152 |
Spring-loaded pneumoperitoneum needle, reusable |
A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. |
B |
| 153 |
Spring-loaded pneumoperitoneum needle, single-use |
A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. |
B |
| 154 |
Static magnetic anal plug |
A non-sterile magnetic device designed to be inserted into the rectum by the user and retained there for a specified period of time (e.g., 1 to 2 hours per day for 10 to 20 days) to help reduce anal haemorrhoids with magnetism. |
B |
| 155 |
Stoma drainage catheter |
A sterile flexible tube that is inserted into a stoma (an artificial opening in the body, especially in the abdominal wall, made during a surgical procedure) to drain bodily waste from an internal stoma container; normally directly into the toilet. |
B |
| 156 |
Stoma support implant |
A sterile, non-bioabsorbable device intended to be implanted into the abdominal wall during a gastro-urological ostomy procedure to reduce the risk of parastomal hernia by supporting the abdominal wall surrounding the stoma. |
C |
| 157 |
TEM/TEO rectoscope, optical |
An endoscope with a rigid inserted portion intended for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO). |
B |
| 158 |
TEM/TEO rectoscope, video |
An endoscope with a rigid inserted portion intended for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO). |
B |
| 159 |
Thermal-regulation orogastric tube |
A non-sterile, multi-lumen, multi-purpose tube intended for oral introduction into the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric decompression; and 2) thermal regulation of the whole body via thermal transfer across the oesophagus (to lower and alternatively elevate core body temperature). |
C |
| 160 |
Transenteric drainage tube |
A sterile non-bioabsorbable tube intended to be endoscopically implanted transmurally between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract for drainage. |
C |
| 161 |
Video capsule endoscopy system |
An assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. |
B |
| 162 |
Video capsule endoscopy system application software |
An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and analysis capabilities to a video capsule endoscopy system. |
B |
| 163 |
Video capsule endoscopy system capsule |
A non-sterile, battery-powered, electronic component device of a video capsule endoscopy system designed to be swallowed by a patient for the internal visualization and examination of the gastrointestinal (GI) tract. |
B |
| CATEGORY:UROLOGY |
|
|
|
| Sr No. |
Name Of Prouct |
Intended Use |
Current CDSCO Classification |
| 1 |
Bare-metal urethral stent, short-term |
A sterile non-bioabsorbable tubular device intended to be placed short-term (<= 30 days) in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). |
C |
| 2 |
Biliary/urinary stone retrieval basket, reusable |
A flexible manual instrument designed to remove biliary and/or urinary stones (gallbladder and/or renal calculi) from the body during an endoscopic procedure. |
B |
| 3 |
Bladder neck spreader |
A manual gastroenterology-urology surgical instrument with specially designed moveable blades intended to be used to separate and spread the bladder neck. This is a reusable device. |
A |
| 4 |
Bladder-emptying vibratory stimulator |
A battery-powered, hand-held device intended to be used in the home or healthcare facility by a patient to help initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. |
B |
| 5 |
Closed-ended wearable urine collection bag, non-sterile |
A non-sterile flexible plastic pouch designed to connect to a urinary catheter and to be strapped to the leg of a patient to collect discharged urine; it is not designed with an opening for urine drainage. |
A |
| 6 |
Closed-ended wearable urine collection bag, sterile |
A non-sterile flexible plastic pouch designed to connect to a urinary catheter and to be strapped to the leg of a patient to collect discharged urine; it is not designed with an opening for urine drainage. |
A |
| 7 |
Cystometer |
A device used to examine the bladder, providing measurement data concerning pressure and volume. This data will be used for diagnostic evaluation of the neuromuscular mechanisms of the bladder. |
B |
| 8 |
Cystometer probe, ultrasonic |
A device that emits ultrasound energy generated by a cystometer in order to study bladder function by measuring bladder capacity, sensation, pressure, and residual urine. |
B |
| 9 |
Cystoscopic electrode |
A sterile electrical conductor intended to be placed in contact with the bladder to stimulate it and/or record its electrical activity for diagnostic examination. |
B |
| 10 |
Diaphragm wearable urinal |
A non-sterile urine drainage device designed for men with incontinence consisting of a front piece with a scrotal support and a leak-proof, flexible diaphragm through which the penis passes into a closed cone-shaped tube connected to a leg bag into which the urine is collected. |
A |
| 11 |
Draping incontinence liner |
A non-sterile padded sheet intended to cover and protect a device/piece of furniture (e.g., wheelchair, bed, sofa) occupied by an incontinent person by catching and retaining urine. |
A |
| 12 |
Drip wearable urinal |
A non-sterile urine drainage device designed for men to contain a moderate leakage consisting of a front piece with an integrated tubular sheath that fits fully over the penis and into which dribbling urine is collected. |
A |
| 13 |
Electrohydraulic lithotripsy system |
An assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. |
B |
| 14 |
Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use |
A sterile, slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing high-speed fragmentation of the calculus in situ. |
B |
| 15 |
Electromechanical lithotripsy system, extracorporeal |
An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. |
C |
| 16 |
Electromechanical lithotripsy system, intracorporeal |
An assembly of devices designed to create shock waves through electromechanical action for the intracorporeal fragmentation of calculi (stones) in the urinary tract (i.e., kidney, ureter and bladder); the resulting debris may be actively removed or passed out by natural means at a later date. |
B |
| 17 |
Female wearable urinal, reusable |
A non-sterile, urine drainage device designed for women that typically consists of a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. |
A |
| 18 |
Fibreoptic ureteral catheter, reusable |
A flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for illumination to enable the path of the ureter to be seen. It also includes a plug for connection to a fibreoptic light source and a port for irrigation at its proximal end. |
B |
| 19 |
Filiform urethral bougie |
An extremely thin, wire-like, manual surgical instrument designed for traversing and exploring urethral strictures and/or dilating the urethra, introduced directly or through an appropriately-threaded urethral catheter. |
B |
| 20 |
Flexible endoscopic stone retrieval forceps, reusable |
A flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. |
B |
| 21 |
Flexible fibreoptic cystonephroscope |
An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. |
B |
| 22 |
Flexible fibreoptic cystoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. |
B |
| 23 |
Flexible fibreoptic cystourethroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. |
B |
| 24 |
Flexible fibreoptic nephroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy. |
B |
| 25 |
Flexible fibreoptic ureterorenoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. |
B |
| 26 |
Flexible fibreoptic ureteroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). |
B |
| 27 |
Flexible fibreoptic urethroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine). |
B |
| 28 |
Flexible ureteral sheath/fibreoptic telescope |
A sterile device assembly intended to function as a flexible endoscope for the visual examination and treatment of body cavities/organs that can be accessed via the ureter for cystoscopic, nephroscopic, laparoscopic, and ureteroscopic procedures. |
B |
| 29 |
Flexible video cystonephroscope |
An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, urethra (including prostate region), and kidneys. |
B |
| 30 |
Flexible video cystoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. |
B |
| 31 |
Flexible video cystourethroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. |
B |
| 32 |
Flexible video nephroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the kidney. |
B |
| 33 |
Flexible video ureterorenoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. |
B |
| 34 |
Flexible video ureteroscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). |
B |
| 35 |
Flexible video urethroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine). |
B |
| 36 |
General-purpose ureteral catheter |
A flexible tube designed for introduction into the ureters through a cystoscope or nephroscope. |
B |
| 37 |
Hand pneumatic lithotripsy system, urinary |
An assembly of devices that uses pneumatically-created ballistic shock waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidneys, ureters, and bladder) for their removal. |
B |
| 38 |
Hand-held urinal, female |
A portable, hand-held container/set, typically made of plastic, intended to be directly urinated into by a female (typically bed-bound) patient for excretory purposes. |
A |
| 39 |
Hand-held urinal, male, reusable |
A portable, hand-held container intended to be directly urinated into by a male (typically bed-bound) patient for excretory purposes. |
A |
| 40 |
Hepatic function analysis system |
An assembly of mains electricity (AC-powered) devices intended to aid in the quantitative assessment of liver function by the in vivo measurement of the plasma concentration and clearance of a tracer substance [e.g., indocyanine green (ICG)] in the peripheral vasculature following intravenous injection. |
B |
| 41 |
Home faecal specimen collection kit |
A collection of non-sterile devices and materials intended to be used by a layperson to collect and mail a faecal (stool) sample to a clinical laboratory for diagnostic testing or screening purposes (e.g., occult blood, cytology). |
A |
| 42 |
Hydraulic male urinary incontinence treatment system |
An assembly of implantable devices intended to treat male urinary incontinence by applying pressure to partially/fully occlude the bladder neck and/or urethra, typically after radical prostatectomy or transurethral resection of the prostate. |
C |
| 43 |
Hydraulic male urinary incontinence treatment system port |
An implantable component of a hydraulic male urinary incontinence treatment system intended to provide access to the system’s inflatable pad (e.g., cushion, balloon), for the intra- and/or postoperative introduction/removal of fluid (e.g., saline). |
C |
| 44 |
Hydraulic male urinary incontinence treatment system tubing |
An implantable length of tube that functions as a component of a hydraulic male urinary incontinence treatment system and intended to provide connection between the system’s inflatable pad (e.g., cushion, balloon) and the system’s port, for the intra- and/or postoperative introduction/removal of fluid (e.g., saline); it is typically made of silicone and metal. |
C |
| 45 |
Hydraulic male urinary incontinence treatment system tubing plug |
An implantable component of a hydraulic male urinary incontinence treatment system intended to seal the system’s tubing to prevent spillage/leakage of its contents when introduction/removal of fluid to/from the system’s pad (e.g., cushion, balloon) is not needed; it is typically made of metal. |
C |
| 46 |
Incontinence device suspender |
A device used by a person with a disability to secure a body-worn incontinence device [e.g., a nappy (diaper) or a pad] in a stable and safe position. |
A |
| 47 |
Incontinence pants liner |
A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. |
A |
| 48 |
Incontinence pants, reusable |
An underwear designed to retain urine leakage in incontinent adults and older children. |
A |
| 49 |
Incontinence penis clamp, reusable |
A male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder. |
A |
| 50 |
Incontinence sensor/alarm |
An electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). |
B |
| 51 |
Inflatable penile prosthesis |
An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. |
C |
| 52 |
Intermittent urethral catheterization kit, nonsterile |
A collection of non-sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. |
B |
| 53 |
Intermittent urethral catheterization kit, sterile |
A collection of sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. |
B |
| 54 |
Intermittent urethral drainage catheter, antimicrobial |
A sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. |
B |
| 55 |
Intermittent urethral drainage catheter, nonsterile |
A non-sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. |
B |
| 56 |
Intermittent urethral drainage catheter, sterile |
A sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. |
B |
| 57 |
Intracorporeal lithotripsy suction system |
An assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluid-containing fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy. |
B |
| 58 |
Intraurethral valve/pump |
A sterile, non-powered device intended to be inserted into the female urethra to facilitate urine voiding in patients with incomplete bladder emptying due to impaired detrusor contractility (IDC) of neurologic origin. |
B |
| 59 |
Laser lithotripsy fibre/suction guide |
A sterile device intended to be inserted through the working channel of a rigid nephroscope during laser lithotripsy to function as a channel for insertion of the laser fibre of a laser beam guide (e.g., of a general/multiple surgical laser system), and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. |
C |
| 60 |
Laser lithotripsy system |
An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). |
C |
| 61 |
Lithotrite |
A hand-held manual surgical instrument designed for the mechanical crushing of renal stones (calculi) in the urinary tract and/or bladder. |
B |
| 62 |
Male urinary outflow analysis system |
A mains electricity (AC-powered) assembly of devices intended to be used to measure urine flow rate and to estimate isovolumetric bladder pressure in men with the use of an inflatable penile cuff. It typically consists of a dedicated computer and application software, an automatic cuff inflation/deflation unit, a single-use penile cuff, and a load-measuring cell/stand. |
B |
| 63 |
Male urinary outflow analysis system cuff |
A non-sterile inflatable cuff that is a component of a male urinary outflow analysis system. |
B |
| 64 |
Manometric catheter sheath |
A non-sterile, synthetic polymer sleeve intended to cover/protect and prevent contamination of a manometric catheter (including barostat catheter). |
B |
| 65 |
Microwave hyperthermia system catheter, prostatic-ablation, reusable |
A thin rod intended to be used as part of a hyperthermia system to treat disorders of the prostate [e.g., cancer, benign prostatic hyperplasia (BPH), prostatitis] through the local application of heat from microwaves. |
C |
| 66 |
Penile extracorporeal shock wave therapy system |
A mobile assembly of devices designed to provide spark-gap-generated, low-intensity, extracorporeal shock wave therapy to treat erectile dysfunction (ED) [impotence] to rehabilitate penile erection and rigidity adequate for intercourse. |
B |
| 67 |
Penile extracorporeal shock wave therapy system applicator |
A hand-held device designed to transmit spark-gap-generated (electrohydraulic), low-intensity, shock waves from a penile extracorporeal shock wave therapy system generator to the skin of the penile shaft and the penile crura to treat erectile dysfunction (ED) [impotence] to rehabilitate penile erection and rigidity adequate for intercourse. |
B |
| 68 |
Penis wearable urinal |
A non-sterile, externally-worn, urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag. |
B |
| 69 |
Penis/scrotum wearable urinal |
A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. |
B |
| 70 |
Perineal orifice incontinence-control electrical stimulation system, remote control |
An assembly of battery-powered, remote-controlled devices designed for intravaginal pelvic floor exercise to treat urinary incontinence and other pelvic problems in women (e.g., pelvic pain and sexual dysfunction) through the application of electrical stimuli to the muscles of the pelvic floor. |
C |
| 71 |
Piezoelectric lithotripsy system |
An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a piezoelectric generator. |
C |
| 72 |
Pyeloscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the renal pelvis and major or minor calyces. |
B |
| 73 |
Rigid cystoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. |
B |
| 74 |
Rigid cystourethroscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. |
B |
| 75 |
Rigid nephroscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney. |
B |
| 76 |
Rigid ureterorenoscope |
An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. |
B |
| 77 |
Rigid ureteroscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter, (the upper urinary tract that connects the kidney to the bladder). |
B |
| 78 |
Rigid urethroscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine). |
B |
| 79 |
Rigid video ureterorenoscope |
A sterile endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. |
B |
| 80 |
Spark-gap lithotripsy system |
An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a spark-gap generator. |
B |
| 81 |
Suprapubic needle, surgical, reusable |
A hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with bladder prolapse. |
B |
| 82 |
Temperature-monitoring indwelling urethral drainage catheter |
A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. |
B |
| 83 |
Transobturator needle, reusable |
A hand-held manual surgical instrument with a sharp pyramidal or conical point used to create a percutaneous puncture using the transobturator approach (i.e., the insertion points overlie the obturator space in the genitofemoral crease lateral to the vagina), for the surgical positioning of a sling used in the treatment of stress urinary incontinence (SUI), which may be associated with a prolapse. |
B |
| 84 |
Transvaginal needle, surgical |
A hand-held manual surgical instrument with a sharp pyramidal or conical point designed to create a puncture in the vaginal wall for the surgical positioning of a sling typically used in the treatment of stress urinary incontinence (SUI) associated with bladder prolapse. |
B |
| 85 |
Ultrasonic lithotripsy system |
An assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. |
B |
| 86 |
Ureteral patency kit |
A collection of devices intended to assist treatment of a blocked ureter and to help maintain ureteral patency through natural orifice or percutaneous access. |
B |
| 87 |
Urethral drainage catheter punch |
A hand-held manual instrument designed for cutting a small hole (e.g., 0.3 mm diameter) into the distal end of a closed Foley catheter (usually 14.0 French or larger) to form a "Council tip Foley catheter", allowing it to be placed over a guidewire or ureteral catheter. |
B |
| 88 |
Urethral/suprapubic catheter valve-connector |
A small, sterile valve intended to be connected to a urethral and/or suprapubic catheter to allow intermittent bladder drainage/filling (as an alternative to continuous drainage). |
A |
| 89 |
Urinary-incontinence vaginal insert, reusable |
A non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). |
A |
| 90 |
Urodynamic measurement system |
An assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. |
B |
| General Hospital Medical Devices |
|
|
|
| Sr No. |
Device Name |
Intended Use |
INDIA |
| 1 |
Liquid crystal forehead temperature strip |
A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. |
B |
| 2 |
Bed exit monitor, Fall prevention |
Intended to be placed under mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed. |
A |
| 3 |
Electronic monitor for gravity flow infusion systems |
Inteded to electroncially monitor the amount of fluid being infused into a patient. |
C |
| 4 |
Electrically powered spinal fluid pressure monitor |
Inteded to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal. |
B |
| 5 |
Spinal fluid manometer |
A spinal fluid manometer is a device used to measure spinal fluid pressure using nnedle and graduated column. |
B |
| 6 |
Stand-on patient scale |
Intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform. |
A |
| 7 |
Patient scale |
A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scaleby placing scale under a bed or chair to weigh both the support and the patient. |
A |
| 8 |
Sterilization process indicator (Biological) |
A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization on medical device. |
B |
| 9 |
Sterilization process indicator (Physical/chemical) |
A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process on medical device. |
B |
| 10 |
Clinical color change thermometer |
A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. |
A |
| 11 |
Clinical electronic thermometer |
A clinical electronic thermometer is a device used to measure the body temperature of a patient. |
B |
| 12 |
Clinical mercury thermometer |
A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury. |
B |
| 13 |
Apgar timer |
The Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant. |
A |
| 14 |
Hydraulic adjustable hospital bed |
Intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed. |
A |
| 15 |
Manual adjustable hospital bed |
A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. |
A |
| 16 |
Infant radiant warmer |
Intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. |
C |
| 17 |
Pediatric medical crib |
Intended for medical purposes for use with a pediatric patient. |
B |
| 18 |
Medical bassinet |
Intended for medical purposes in hospital for use (birth to approximately 5 months of age) in a nursery, labor and delivery unit, or patient room. |
B |
| 19 |
Nonpowered flotation therapy mattress |
A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials, to treat or prevent decubitus ulcers (bed sores). |
A |
| 20 |
Therapeutic medical binder |
Intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place like abdominal, breast and perineal binder. |
A |
| 21 |
Burn sheet |
Inteded to wrap aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants |
A |
| 22 |
Neonatal eye pad |
A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy. |
A |
| 23 |
Neonatal incubator |
A neonatal incubator is a device in which an infant may be kept in a controlled environment (humidity, temperature, oxygen etc) for medical care. |
C |
| 24 |
Neonatal transport incubator |
Transport incubator is a device in which an infant may be kept in a controlled environment (humidity, temperature, oxygen etc) while being transported for medical care. |
C |
| 25 |
Pressure infusor for an I.V. bag |
Device inteded to inflate and increases the pressure on the I.V. bag to assist the infusion of the fluid |
B |
| 26 |
Intravascular administration set, automated air removal system |
Inteded to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid. |
B |
| 27 |
Patient care reverse isolation chamber |
Device inteded protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. |
B |
| 28 |
Jet lavage |
A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. |
C |
| 29 |
Patient lift, Electrcially powered |
Inteded to lift and transport patients in hsoptial in the horizontal or other required position from one place to another, as from a bed to a bath. |
B |
| 30 |
Nipple shield |
A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. |
A |
| 31 |
Lamb feeding nipple |
A lamb feeding nipple is a device intended for use as a feeding nipple for infants with oral or facial abnormalities |
A |
| 32 |
Neonatal phototherapy unit |
A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). |
B |
| 33 |
Infusion pump |
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. |
C |
| 34 |
Suction snakebite kit |
Intended for removing venom from the wound. |
A |
| 35 |
Chemical cold pack snakebite kit |
Intended for first-aid treatment of snakebites |
C |
| 36 |
Therapeutic scrotal support |
Intended for medical purposes to support the scrotum (the sac that contains the testicles) |
A |
| 37 |
Umbilical occlusion device |
An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant. |
A |
| 38 |
Cardiopulmonary resuscitation board |
Intended to be placed under a patient to act as a support during cardiopulmonary resuscitation. |
A |
| 39 |
Ultrasonic cleaner for medical instruments |
Intended for cleaning medical instruments by the emission of high frequency soundwaves |
B |
| 40 |
Sharps needle destruction device |
Intended to destroy needles or sharps used for medical purposes by incineration or mechanical means. |
B |
| 41 |
Medical insole |
Intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete's foot infection by absorbing moisture. |
A |
| 42 |
Ingestible event marker |
An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial |
C |
| 43 |
Remote Medication Management System |
The system is intended to store the patient's prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patient's prescribed medications, to notify the patient when the prescribed medications are due to be taken, to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command, and to record a history of the event for the health care professional. |
B |
| 44 |
Surgical Light, Single or Multi dome |
Intended for medical purposes that is used to illuminate body surfaces and cavities during Surgery. |
B |
| 45 |
Medical examination light, AC powered or Battery |
Intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination. |
B |
| 46 |
Skin pressure protectors |
A skin pressure protector is a device intended to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores) |
A |
| 47 |
Medical ultraviolet air purifier |
A medical ultraviolet air purifier is a device intended for medical purposes in hospital/clinic to destroy bacteria in the air by exposure to ultraviolet radiation. |
B |
| 48 |
Ultraviolet (UV) radiation chamber disinfection device |
An ultraviolet (UV) radiation chamber disinfection device is intended for the low-level surface disinfection of nonporous medical device surfaces by dose-controlled UV irradiation. |
C |
| 49 |
Body waste receptacle |
A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient. |
A |
| 50 |
Vacuum-powered body fluid suction apparatus |
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. |
B |
| 51 |
Washers for body waste receptacles |
A washer for body waste receptacles is a device intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan. |
B |
| 52 |
Sterilization wrap |
It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used |
B |
| 53 |
Ethylene oxide gas sterilizer |
Intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical devices. |
C |
| 54 |
Dry-heat sterilizer |
A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical devices by means of dry heat. |
C |
| 55 |
Steam sterilizer |
A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical devices by means of pressurized steam. |
C |
| 56 |
Liquid chemical sterilants/high level disinfectants |
A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. |
C |
| 57 |
General purpose disinfectants |
A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. |
B |
| 58 |
Hand-carried stretcher |
A hand-carried stretcher is a device intended to carry patient as an assistance for injury or disability. |
A |
| 59 |
Wheeled stretcher |
A wheeled stretcher is a device intended to transport patients in a horizontal position as an assistance to injury or disability. |
C |
| 60 |
Liquid crystal vein locator |
Inteded to indicate the location of a vein by revealing variations in the surface temperature of the skin. |
A |
| 61 |
Medical washer |
Intended for general medical purposes to clean and dry medical devices, which later undergo sterilization or disinfection before use on patient. |
B |
| 62 |
Medical washer-disinfector |
A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices. |
C |
| 63 |
Hydrogen Peroxide Gas Plasma Sterilization System |
Intended for sterilization/disinfection of both metal and nonmetal/polymer based medical devices. |
C |
| 64 |
Blood grouping slides |
Blood grouping slides are glass surfaces intended to perform the test for finding the blood group. |
A |
| 65 |
Blood bank pipettes |
Blood bank pipettes are disposable blood handling equipment intended to transfer blood from one surface to another. |
A |
| 66 |
Blood mixing and blood weighing devices |
A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. Also intended to weigh blood or blood components as they are collected. |
A |
| 67 |
Blood Vacutainer |
Intended for the drawing of a predetermined volume of blood using vacuum to a container containing Ethylenediaminetetraacetic acid. |
B |
| 68 |
Blood bank centrifuge |
Intended to separate blood components of a suspension by application of centrifugal force. |
A |
| 69 |
Environmental chamber for storage of platelet concentrate |
A refrigerated environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range. |
C |
| 70 |
Blood storage refrigerator |
These are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures. |
C |
| 71 |
Heat-sealing device |
A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components. |
A |
| 72 |
Automated blood cell separator |
The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further clinical use. |
C |
| Operation Theatre Medical Devices |
|
|
|
| S.NO. |
Name Of Prouct |
Intended Use |
IMDR |
1 |
Distractor/Retractors |
A surgical device used to separate connected surfaces, and to retain their positions to allow a surgical operation to be performed. |
A |
| 2 |
Suction system portable, Electrical/Pneumatic |
A device that generates negative pressure used for such treatment as the aspiration of liquid or granular substances. |
A |
| 3 |
Suction system operated by vacuum |
A device used for such treatment as the aspiration of liquid or granular substances by using negative pressure supplied by the hospital's medical gas supply system at bedside for using on the patient. |
A |
| 4 |
Operation table system |
A complete surgical table system intended to change the patient's position and enable attaching various table accessories that aid in surgery. |
A |
| 5 |
General-purpose diagnosis/treatment table |
A table for general diagnosis and procedures in the examination room to aid in patient examination. |
A |
| 6 |
Surgical light system |
An illuminator device intended to providing optimal light and color rendering to aid in performing surgery. |
A |
| 7 |
Hemostatic clip applier |
A surgical device designed to apply a hemostatic clip for ligation of a blood vessel. |
B |
| 8 |
Hemostatic knife |
The blade intended to transmit heat directly to body tissues to achieve hemostasis. |
B |
| 9 |
Scalpel |
An instrument used to sever and separate body tissues during surgery. |
B |
| 10 |
Scalpel blade |
A blade intended to be attached to the handle of a scalpel. |
B |
| 11 |
Surgical forceps |
A surgical or dental device that is used to clamp and sever the cartilage, bone, and other hard tissues. |
B |
| 12 |
General-purpose electrosurgical unit |
A unit used to resect/ablate the tissue or to coagulate the incision/wound site with high-frequency waves. |
C |
| 13 |
Long-term use enterostomy feeding tube |
A hollow device to be placed surgically in the stomach, duodenum, or jejunum to provide enteral nutrition. It is for long-term use. |
C |
| 14 |
Gastrostomy tube for long-term use |
A hollow device to be placed surgically in the stomach, duodenum, or jejunum for enteral nutrition, etc. It is for long-term use. |
C |
| 15 |
Warming high-flow infusion pump |
A device to be used for heating and rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries. |
C |
| 16 |
High-flow blood transfusion pump |
A device to be used for rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries. |
C |
| 17 |
Staple remover |
A metal or plastic surgical instrument used to remove staples from a surgical wound or incision that no longer requires stapling to stay closed. |
B |
| 18 |
Surgical punch |
A surgical instrument used to create a hole for suturing or anastomosis of tissue, blood vessel, etc. |
B |
| 19 |
Surgical file |
A manually operated, hand-held surgical instrument with a series of bumps or teeth on its surface that is used to smooth out, grind off, or sever tissues. |
B |
| 20 |
Blood vessel surgical stripper |
A surgical instrument used for complete or partial vascular resection. |
B |
| 21 |
Surgical probe |
The device used to explore sinuses, fistulae, and other cavities and wounds. |
B |
| 22 |
Multiparameter monitor with critical parameters |
A unit that collects monitoring parameters (including an electrocardiogram (ECG), blood pressure, body temperature, cardiac output, and respiratory gases; in addition to other critical parameters) using an embedded function kit, module, or other devices to display data, by bed or by patient. |
C |
| 23 |
Surgical robot unit |
An operation support device used in open surgery or endoscopic surgery that performs treatment of tissues including suturing, detaching and severing, and installing a prosthesis. |
C |
| 24 |
Motorized diagnostic imaging view box |
A device equipped with an electric mechanical or software controlled motor that retains, retrieves, and projects light for direct observation of medical images taken using a variety of methods such as X-ray, magnetic resonance (MR), CT, and ultrasound, and recorded in radiographic film. |
A |
| 25 |
General-purpose manually-operated operation table |
A completely mobile surgical table (general-purpose) that has been improved to make it usable for almost all parts of the body that require surgery. Manual or hydraulic operation. |
A |
| 26 |
Powered general-purpose operation table |
A completely mobile surgical table (general-purpose) that has been improved to make it usable for almost all parts of the body that require surgery. Electrically line or battery operated. |
B |
| 27 |
Operation table system |
A system that consists of several components that form a complete surgical table system. It is used to replace tabletops, change the patient's position, and transfer the patient to and from the operating room. Usually, it consists of columns, a removable tabletop, remote controller for the trolley, and a trolley. |
B |
| CATEGORY: RESPIRATORY |
|
|
|
| S.NO. |
Medical Device Name |
Intended Use |
INDIA |
| 1 |
Activated-oxygen generator |
It is a device that makes activated oxygen (singlet oxygen) which is mixed with room air and produces activated water as a by-product. |
B |
| 2 |
Aerosol inhalation monitor |
It is a device that enables a medical professional to objectively assess in detail how the test subject uses their inhaler. |
B |
| 3 |
Airway device cleaning utensil |
A hand-held device intended to be used to clean an in situ and ex situ airway device. |
A |
| 4 |
Airway tube forceps |
A hand-held instrument used for grasping a tube for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways. |
A |
| 5 |
Argon gas analyser |
An instrument intended to measure the concentration (partial pressure) of argon (Ar) in a gas mixture sample to aid in determining a patient's ventilatory status. |
B |
| 6 |
Artificial airway tube cuff pressure monitor |
A device intended to intermittently or continuously measure the internal pressure in the cuff of an endotracheal (ET)/endobronchial/tracheostomy tube when this has been situated into the tracheal passage. |
B |
| 7 |
Artificial airway washing/disinfection jar |
A container intended to hold artificial airway devices to facilitate their washing/disinfection. |
C |
| 8 |
Breathing circuit bag |
A device intended to store breathing gas during the respiratory cycle. |
A |
| 9 |
Breathing circuit washer/disinfector |
A device intended for the cleaning and high-level disinfection of breathing circuit components used in respiratory therapy and anaesthesia equipment. |
C |
| 10 |
Bronchoscope |
An endoscope with an inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs and take biopsies and sample of secretions. |
B |
| 11 |
Bulk oxygen concentration system |
An assembly of devices designed to concentrate medical grade oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 93%-99.5%, to the hospital medical gas supply system for therapeutic use on patients in Hospital. |
A |
| 12 |
Cardiopulmonary resuscitation mask |
A device that intended to be placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). |
A |
| 13 |
Cerebral oximeter |
A device used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a patient. |
B |
| 14 |
Chest-oscillation airway secretion-clearing system |
Devices designed to provide high frequency chest wall oscillation (HFCWO) for external chest wall manipulation intended to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. |
B |
| 15 |
Chest-percussion airway secretion-clearing system |
Devices designed to provide external mechanical percussion (rapid tapping) to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. |
B |
| 16 |
Cold-air diagnostic inhalation system |
An assembly of devices intended to be used in the assessment of a patient suffering from asthma. |
B |
| 17 |
Cough long-term ambulatory recording system |
An assembly of devices intended for long-term detection and recording of the number of times a patient coughs during daily activities or sleep. |
A |
| 18 |
Cricothyrotome |
A hand-held manual surgical instrument intended to be used to perform a cricothyrotomy providing airway access within seconds for immediate ventilation of the patient and necessary suction procedures. |
B |
| 19 |
Diagnostic spirometer |
A device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function. |
B |
| 20 |
Dry powder inhaler |
A hand-held device designed to administer powdered medicine through the mouth and into the bronchial airways. |
A |
| 21 |
Dry salt therapy device |
A hand-held inhaler prefilled with salt crystals and used to provide an inhalation of salt particles through the mouth and into the bronchial airways to induce natural self-cleansing mechanisms that flush away the impurities from the surface of cells and mechanically clean the airways. |
A |
| 22 |
Electroacoustical airway secretion-clearing system |
An assembly of devices designed to provide externally applied vibrations to the chest wall of a patient via an electroacoustical transducer (the applicator) to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. |
B |
| 23 |
Electronic oesophageal stethoscope |
An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. |
B |
| 24 |
Endotracheal tube introducer |
A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. |
A |
| 25 |
Exhaled-gas oesophageal intubation detector |
A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. |
A |
| 26 |
Foetal pulse oximeter |
A photoelectric device designed for the monitoring of intrapartum foetal oxygen saturation (FSpO2) in the presence of a non-reassuring foetal heart rate (FHR) pattern during labour. |
B |
| 27 |
Gas pipeline/supply system air compressor |
A device designed to create compressed medical grade air, and supply it to a hospital or institution's gas pipeline/supply system for patient use. |
A |
| 28 |
Heated respiratory humidifier |
A device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy. |
B |
| 29 |
Home-use sleep apnoea recording system |
A device intended to continuously measure and record patient physiological parameters during sleep in the home, to facilitate the diagnosis of sleep apnoea. |
B |
| 30 |
Hyperbaric chamber |
The intended use of the Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient. |
C |
| 31 |
Hypopnea sensor/alarm |
An electronic device intended to be used to indicate patient hypopnea by monitoring the movement of the thorax and abdomen with each breath and provides a signal, according to predetermined settings. |
B |
| 32 |
Impedance pneumography recording/analysis system |
An assembly of electronic devices intended for continuous recording of a patient’s pulmonary function parameters using impedance pneumography (IP). |
B |
| 33 |
Implantable sleep apnoea treatment system |
An assembly of devices intended for home management of obstructive sleep apnoea (OSA) using an implanted stimulator to provide electrical stimulation to the hypoglossal nerve. |
D |
| 34 |
Infant apnoea monitor |
A device that is used to register the respiratory rate of an infant and which gives an alarm signal (e.g., audible/visual) when the pre-set limits are exceeded caused by an extended interruption or cessation (apnoea) of the infants breathing pattern; a condition known as sudden infant death syndrome (SIDS). |
B |
| 35 |
Intracardiac oximeter |
A photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation. |
B |
| 36 |
Intravascular oximeter |
An instrument designed for the continuous in vivo measurement of venous blood oxygen saturation (SvO2). |
B |
| 37 |
Invasive arterial pressure cardiac output/oximetry monitor |
A device intended to continuously measure and display arterial pressure cardiac output (APCO) and haemoglobin oxygen saturation (e.g., SpO2) |
B |
| 38 |
Manual chest percussor |
A hand-held device designed to facilitate manual percussion (rapid tapping) to provide external vibrations to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. |
B |
| 39 |
Medical/surgical string |
A sterile slender cord or thick thread, medical grade, designed to temporarily lift vessels, hold tracheostomy tubes in place, or assist in stabilizing various organs, medical instrumentation and accessories. |
B |
| 40 |
Monitoring spirometer |
A device designed to measure continuously a patient's tidal volume or minute volume for the evaluation of the patient's ventilatory status. |
B |
| 41 |
Negative-pressure ventilator |
An automatic cycling machine used to assist or control alveolar respiration that exerts a negative pressure on the external surface of the chest wall, expanding the chest and moving air into the lungs. |
C |
| 42 |
Nitrogen monoxide analyser |
A device intended to measure nitric oxide (NO), in exhaled air to facilitate diagnosis and management of asthma. |
B |
| 43 |
Nitrous oxide analyser |
An instrument used to measure the concentration of nitrous oxide (N2O) in a sample of a gas mixture taken from an enclosed environment such as a healthcare facility, a compressed medical air or gas system, and/or devices used for anaesthesia administration or respiratory therapy. |
B |
| 44 |
Oxygen concentrator |
A device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2 to patient. |
B |
| 45 |
Pneumatic chest percussor |
A hand-held pneumatic device designed to provide external vibrations to the chest wall of a patient to loosen excessive airway secretions to promote airway clearance and improve bronchial drainage for patients with respiratory disease. |
B |
| 46 |
Public respirator (2 ply, 3 ply face mask) |
A filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency. |
B |
| 47 |
Pulmonary function analysis system |
A device used to measure the function of the respiratory system in adults and compliant children. |
B |
| 48 |
Pulse oximeter |
A device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). |
C |
| 49 |
Pulse oximetry telemetric monitoring system |
An assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location for viewing. |
B |
| 50 |
Respiration monitor |
A device designed to measure and display a non-ambulatory patient's respiratory functions. |
B |
| 51 |
Respiratory apnoea monitoring system |
An assembly of devices designed to detect the cessation of breathing (apnoea) in patient who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). |
B |
| 52 |
Steam inhaler |
An electrically-powered, hand-held device designed for the inhalation of steam for the relief of the symptoms (congestion and pressure) associated with upper respiratory disorders. |
A |
| 53 |
Stress test treadmill |
A device used as a component of a stress test system that permits the evaluation of a patient's physiologic response to physical stress. |
A |
| 54 |
Therapeutic air ionizer |
A device that produces small, biologically-active, negatively-charged ions of oxygen (O2), pulsed at various selected frequencies, that are emitted into the ambient air and absorbed into the bloodstream via the lungs to potentially produce a therapeutic effect. |
A |
| 55 |
Therapeutic positive pressure breathing ventilator |
A device used for therapeutic rehabilitation of patients with chronic respiratory diseases, and for the distribution of aerosolized pharmacological agents to the patient's airways and lungs. |
C |
| 56 |
Thoracic bioconductance measurement system |
An assembly of devices designed to measure and store bioconductance measurements, analyse the stored data and provide information that can aid a clinician in their evaluation of lesions suspicious of lung cancer. |
B |
| 57 |
Thoracic electrical impedance segmentography system |
An assembly of devices designed to perform thoracic bio-impedance measurements to continuously record the distribution of air across 4 quadrants of the lungs, commonly of a neonatal/infant patient to detect changes in lung ventilation at a regional level, to assist in the diagnosis of lung conditions. |
B |
| 58 |
Thoracic electrical impedance tomography system |
An assembly of devices designed to perform continuous bio-impedance measurements throughout a cross-section of the thorax, to provide real-time feedback of lung function of a ventilated patient. |
C |
| 59 |
Thoracic suction pump |
A device intended to generate negative pressure specifically for aspiration, to remove fluids, secretions and air to allow for the normal expansion/function of the lungs and/or mediastinum. |
B |
| 60 |
Tongue-adjustment sleep apnoea treatment system |
An assembly of devices intended for home management of obstructive sleep apnoea (OSA) by monitoring breathing parameters during sleep to detect the onset of an apnoea event and reducing pharyngeal obstruction by the tongue. |
B |
| 61 |
Tracheostoma protective filter |
A device designed as a filter for protecting a stomal opening in the windpipe against harmful external influences. |
A |
| 62 |
Tracheostoma protector |
A patient-worn device in the form of a patch, collar, or cloth designed to be fastened around the neck to protect a tracheostoma orifice against harmful external influences. It is not intended to be used as a shower shield. |
B |
| 63 |
Tracheostomy tube lubricant |
A substance made of oil designed to be applied by healthcare staff or a patient to the outer surface of a tracheostomy tube inner cannula to facilitate its easy sliding into the outer cannula. |
A |
| 64 |
Tracheotome |
A surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy). |
B |
| 65 |
Transcutaneous blood gas monitoring system |
An assembly of devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters detected through the jugular vein (SjvO2). |
B |
| 66 |
Ultrasonic cough stimulation system |
An assembly of devices designed to stimulate a reflex cough using ultrasound in a patient who cannot cough on command, typically respiratory patients with cortical insufficiency or the very young/elderly, to help clear the lungs of secretions and aspirated materials. |
A |
| 67 |
Ultrasonic respiratory humidifier |
A device designed to agitate water into micro-particles with ultrasound to add moisture to the flow of air/gases administered to a patient via a breathing tube/circuit. |
B |
| 68 |
Vacuum-assisted airway secretion clearing system |
A device assembly designed to remove excessive secretion from the lungs and upper airway of patients with respiratory disease or during cardiac rehabilitation through vacuum technology. |
B |
| 69 |
Valsalva manoeuvre mouthpiece |
A device intended to be inserted into a patient's mouth to facilitate performance of the Valsalva manoeuvre. |
A |
| 70 |
Video intubation laryngoscope handle/monitor |
A component of a bladed video intubation laryngoscope intended to enable the positioning of the blade into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. |
A |
| 71 |
Whole-body plethysmograph |
A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. |
B |
| CATEGORY: Neurological |
|
|
|
| S.NO. |
Device Name |
Intended Use |
Current CDSCO Classification |
| 1 |
Analgesic PENS system |
Intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve as relief of chronic neuropathic pain. |
B |
| 2 |
Analgesic spinal cord electrical stimulation system |
Implantable device intended to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective. |
D |
| 3 |
Analgesic TENS system |
Intended to treat pain by transcutaneous electrical simulation on peripheral nerves. |
B |
| 4 |
Analytical non-scalp cutaneous electrode |
Electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring. |
A |
| 5 |
Analytical non-scalp cutaneous lead |
Intended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. |
A |
| 6 |
Analytical scalp electrode |
Intended to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. |
B |
| 7 |
Analytical scalp lead |
Intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals during encephalography (EEG). |
B |
| 8 |
Aneurysm clip |
An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting. |
D |
| 9 |
Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system |
Implantable device intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). |
D |
| 10 |
Arthritis TENS system |
Intended in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). |
B |
| 11 |
Atrial cerebrospinal fluid catheter |
Intended to be implanted as the distal component of a ventriculoatrial shunt to channel cerebrospinal fluid (CSF) to the right atrium where it can be absorbed into the body. |
D |
| 12 |
Autonomic neuropathy heart rate meter |
Intended to diagnose autonomic nervous system dysfunction (autonomic neuropathy). |
C |
| 13 |
Back/leg/chest dynamometer |
Intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. |
A |
| 14 |
Bare-metal intracranial vascular stent |
Intended to be implanted into the base or parent artery of an intracranial aneurysm. |
D |
| 15 |
Behavioural therapy electrical stimulation system |
Intended in the treatment of obsessive/compulsive behaviour and drug abuse, by applying electrical impulse(aversion therapy). |
C |
| 16 |
Bladder/bowel-evacuation implantable electrical stimulation system |
Intended to empty the urinary bladder and/or the bowels by applying electrical stimuli typically to the cone-shaped end of the spinal cord (conus medularis). |
D |
| 17 |
Brain injury adjunctive interpretive electroencephalograph assessment aid. |
A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. |
C |
| 18 |
Brain-responsive electrical stimulation system |
Intended to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to neurological disorders (e.g., epilepsy). |
D |
| 19 |
Cardiac-therapy vagus nerve electrical stimulation system |
Intended to apply periodic stimuli to the vagus nerve as a treatment for cardiac failure. |
D |
| 20 |
Cerebral perfusion catheter |
Intended for brain protection during profound hypothermic circulatory arrest during aortic surgery. |
D |
| 21 |
Cerebrospinal fluid manometer |
Intended to measure the cerebrospinal fluid (CSF) pressure/intracranial pressure via lumbar puncture. |
C |
| 22 |
Cerebrospinal fluid shunt valve programmer |
Intended to noninvasively modify the operating pressure of a programmable, non-active, implanted cerebrospinal fluid (CSF) shunt valve that is part of a CSF shunt. |
C |
| 23 |
Coma-arousal vagus nerve electrical stimulation system |
Intended to apply periodic stimuli to the vagus nerve for the purpose of exciting the patient to arousal from a vegetative state (i.e., a deep coma). |
D |
| 24 |
Computerized cognitive assessment aid. |
The computerized cognitive assessment aid is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function. The computerized cognitive assessment aid is used only as an assessment aid to determine level of cognitive functioning for which there exists other valid methods of cognitive assessment and does not identify the presence or absence of clinical diagnoses. The computerized cognitive assessment aid is not intended as a stand-alone or adjunctive diagnostic device. |
C |
| 25 |
Cortical electrode. |
A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity |
D |
| 26 |
Cranial bur, |
Intended to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. |
A |
| 27 |
Cranial electrotherapy stimulator. |
A cranial electrotherapy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety |
D |
| 28 |
Cranial perforator |
Metallic rotary endpiece designed to cut a hole(s) or a circular section(s) of the skull vault (calvarium) by attaching to powered drill/handpiece. |
B |
| 29 |
Cranial trephine |
Intended as a neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior. |
A |
| 30 |
Craniotomy power tool system handpiece |
Intended to be used to rotate a cranial cutting tool (i.e., a drill bit, bur, trephine or perforator) in order to produce a hole or holes in the skull vault (calvarium). |
C |
| 31 |
Cryogenic surgical device |
A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site. |
D |
| 32 |
Cutaneous electrode |
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. |
C |
| 33 |
Deep brain electrical stimulation system |
Designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders, psychiatric disorders and/or to treat chronic, severe, intractable pain. |
D |
| 34 |
Deep brain electrical stimulation system lead |
Intended to be implanted in specific areas of the deep brain and used along with deep brain electrical simulation system. |
C |
| 35 |
Depth electrode |
A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain. |
C |
| 36 |
Diagnostic peripheral nerve electrical stimulation system |
Intended to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. |
C |
| 37 |
Diagnostic somatosensory tactile stimulation system |
Intended to be used to apply tactile stimuli to the body (e.g., pneumatic activation of a membrane to the fingers and lips) typically for evoked response procedures to investigate the function and potential disorders of the brain. |
B |
| 38 |
Diskectomy system, percutaneous, automatic |
Intended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc. |
D |
| 39 |
Dura mater sealant |
Intended to be applied to sutured dura mater to prevent cerebrospinal fluid (CSF) leakage during healing. |
C |
| 40 |
Echoencephalograph. |
An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head. |
C |
| 41 |
Ejaculation electrical stimulation system |
Intended to apply electrical stimuli to the nerves that control ejaculation. |
C |
| 42 |
Electroconvulsive therapy system |
Intended to apply strong electrical stimuli to a patient's brain to induce convulsions and loss of consciousness, typically to treat major depression, schizophrenia, or mania. |
C |
| 43 |
Electroencephalogram (EEG) signal spectrum analyzer. |
An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal. |
B |
| 44 |
Electroencephalograph electrode/lead tester. |
An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin. |
B |
| 45 |
Electroencephalograph test signal generator. |
An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph. |
B |
| 46 |
Electroencephalograph tester |
Intended to perform quality control procedures on an electroencephalograph (EEG) machine and/or a sleep recording machine. |
A |
| 47 |
Electroencephalograph |
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. |
C |
| 48 |
Electroencephalographic electrode cap |
Analytical scalp electrodes preconfigured within a head-worn device to use with electroencephalography (EEG). |
B |
| 49 |
Electroencephalographic long-term ambulatory recorder |
Intended to continuously record electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders. |
B |
| 50 |
Electroencephalographic monitoring system |
Intended to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. Along with which measuring of other physiological parameters such as electromyogram (EMG), respiration waveforms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. |
C |
| 51 |
Electroencephalographic simulator |
Intended to produce artificial physiological signals or replays digitally recorded patient data to perform rapid testing, simulating that of an electroencephalograph (EEG) recorder or monitor. |
B |
| 52 |
Electromyograph |
Intended in clinical diagnosis of muscular disorders to evaluate muscle weakness and to determine if the weakness is related to the muscles themselves or a problem with the nerves that supply the muscles. |
B |
| 53 |
Electronystagmograph |
Intended for detecting the electrical potential caused by eye movements. |
B |
| 54 |
Epicranial brain electrical stimulation system |
Intended to apply weak, pulsed (not continuous) electrical stimuli from beneath the scalp to specific areas of the brain for the treatment of focal epilepsy. |
C |
| 55 |
Esthesiometer. |
An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity. |
A |
| 56 |
Extramuscular diaphragm/phrenic nerve electrical stimulation system |
Intended to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve, to contract the diaphragm rhythmically (using extramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing. |
D |
| 57 |
Facial nerve locating system |
Intended to locate a facial nerve by applying an electrical stimulus. |
B |
| 58 |
Gait-enhancement electrical stimulation system, external |
Intended to improve the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders by applying external electrical stimulation. |
B |
| 59 |
Gait-enhancement electrical stimulation system, implantable |
Intended to improve the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders by applying internal electrical stimulation. |
D |
| 60 |
Gustometer |
Intended to measure the threshold of a patient's taste by applying a variable direct current to the tongue. |
B |
| 61 |
Hand dynamometer/pinchmeter, electronic |
An electronically powered instrument intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object and as part of interactive rehabilitation. |
A |
| 62 |
Hand dynamometer/pinchmeter, mechanical |
A mechanical instrument intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object and as part of interactive rehabilitation. |
A |
| 63 |
Home seizure monitoring system |
Intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. |
C |
| 64 |
Human dura mater |
Human pachymeninx tissue intended to repair defects in human dura mater. |
D |
| 65 |
Implantable intrathecal infusion pump, programmable |
Intended to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. |
D |
| 66 |
Implantable lumbar neuromuscular electrical stimulation system programmer |
Intended to be used by a healthcare professional to telemetrically program the implantable (lumbar neuromuscular electrical stimulation system) pulse generator component with patient-specific parameters. |
C |
| 67 |
Implantable lumbar neuromuscular electrical stimulation system pulse generator |
Intended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain (CLBP). |
D |
| 68 |
Implantable pulse generator mesh bag, bioabsorbable |
Intended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator, neurostimulator) to stabilize the implant in the subcutaneous pocket in which it is implanted. |
D |
| 69 |
Implantable sleep apnea treatment system |
Intended to deliver electrical stimulation to the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)] for the home management of obstructive sleep apnea (OSA). |
D |
| 70 |
Implantable sleep apnea treatment system programmer/charger |
Intended to be used by the patient to communicate telemetrically with an implanted pulse generator to control therapy, and recharge the pulse generator's battery. |
C |
| 71 |
Implantable sleep apnea treatment system, respiration-sensing |
Intended to deliver electrical stimulation in synchronous with respiration during sleep, to the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)] for the home management of obstructive sleep apnea (OSA). |
D |
| 72 |
Implantable spinal cord electrical stimulation system programmer |
Device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). |
C |
| 73 |
Implanted cerebellar stimulator |
An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's cerebellum and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver |
D |
| 74 |
Implanted diaphragmatic/phrenic nerve stimulator |
An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver |
D |
| 75 |
Implanted intracerebral/subcortical stimulator for pain relief |
An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver |
D |
| 76 |
Implanted neuromuscular stimulator |
An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patient's nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patient's shoe |
D |
| 77 |
Implanted spinal cord stimulator for bladder evacuation |
An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver |
D |
| 78 |
Interferential electrical stimulation system |
Intended to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage. |
B |
| 79 |
Intracranial pressure monitor device |
Intended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device. |
D |
| 80 |
Intramuscular diaphragm/phrenic nerve electrical stimulation system |
Intended to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve to contract the diaphragm rhythmically (using intramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing. |
D |
| 81 |
Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer |
Intended to change, telemetrically, one or more of the operating parameters (the programs) of an intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator (EPG). |
C |
| 82 |
Intranasal cooling system |
Intended for rapid cooling induction in patients where temperature reduction is clinically indicated (e.g., following a cerebral ischemic event, during cardiac arrest) to help minimize damage to the brain and heart. |
C |
| 83 |
Intranasal lacrimal neurostimulator |
Intended to be used in the home to provide electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye. |
C |
| 84 |
Invasive-detection physiological monitor |
Intended for continuous or intermittent measurement, display and/or recording of several invasively-detected physiological parameters [e.g., intracranial pressure (ICP), compartmental pressure]. |
C |
| 85 |
Leukotome |
Intended to cut brain tissue (i.e., cutting white matter, leukotomy). |
B |
| 86 |
Magnetoencephalography system |
Intended to non-invasively detect, measure, and display bio-magnetic signals produced by electrically-active cortical brain tissue, and that provide diagnostic information about the location of the active tissue responsible for cognitive brain functions relative to the surrounding brain anatomy. |
B |
| 87 |
Manual goniometer |
Intended to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. |
A |
| 88 |
Manual surgical saw, flexible |
Intended for cutting bone through a sawing action during neurological or orthopedic surgery. |
B |
| 89 |
Meningeal prosthesis |
Intended to repair the meningeal membrane (meninges). |
D |
| 90 |
Nasopharyngeal electrode |
A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity. |
C |
| 91 |
Needle electrode |
A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals. |
C |
| 92 |
Nerve conduction velocity measurement device |
A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time. |
C |
| 93 |
Nerve guide, bioabsorbable, animal-derived |
Collagen matrix material intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. |
D |
| 94 |
Nerve guide, bioabsorbable, synthetic |
Synthetic material intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. |
D |
| 95 |
Nerve guide, non-bioabsorbable |
Non-bioabsorbable material intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. |
D |
| 96 |
Neurological endoscope |
A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain. |
C |
| 97 |
Neurological stereotactic surgery system |
Intended to store diagnostic images used for image-guided neurosurgery. |
C |
| 98 |
Neuromuscular transmission electrical skin sensor |
Intended to detect electrical neuromuscular transmission (NMT) signals, for assessing the degree of neuromuscular block in a patient. |
C |
| 99 |
Neuromuscular transmission motion sensor |
Intended to be placed on the thumb and index finger of a patient to detect movements and convert them into electrical neuromuscular transmission (NMT) signals during nerve stimulation. |
B |
| 100 |
Neurophysiologic monitoring system |
Devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care. |
B |
| 101 |
Neuropsychiatric interpretive electroencephalograph assessment aid |
The neuropsychiatric interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. The neuropsychiatric interpretive EEG assessment aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. |
C |
| 102 |
Neurosurgical chair |
Intended to support and position a patient in a sitting or reclined position during neurosurgery. |
A |
| 103 |
Neurosurgical head holder (skull clamp) |
A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures. |
B |
| 104 |
Neurosurgical headrests |
A neurosurgical headrest is a device used to support the patient's head during a surgical procedure. |
A |
| 105 |
Neurosurgical microscope |
Designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light. |
B |
| 106 |
Neurosurgical ultrasound navigation system |
Intended for intraoperative imaging of the brain for precise navigation during brain surgery (e.g., resection of malignant brain tumors, treatment of vascular malformations). |
B |
| 107 |
Non-electroencephalogram (EEG) physiological signal based seizure monitoring system |
A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure |
C |
| 108 |
Nonpowered neurosurgical instrument |
A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc |
A |
| 109 |
Olfactometry system |
Intended to determine the response of humans to odors delivered through the nose, including irritants. |
C |
| 110 |
Otoacoustic emission system |
Intended to record and analyze the faint sounds hair cells in the inner ear emit in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. |
B |
| 111 |
Percussion hammer, manual |
Intended to be used by an examining physician to gently tap near a patient's joints to test reflexes. |
A |
| 112 |
Percussor |
A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations |
A |
| 113 |
Photodiode subretinal prosthesis system |
Designed to provide visual function to a patient with vision loss due to retinal degeneration by detecting light, converting it into electrical signals, and relaying them to the retina for neural stimulation. |
C |
| 114 |
Physical therapy ultrasound/neuromuscular stimulation system |
Designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments. |
B |
| 115 |
Pinwheel |
A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation |
A |
| 116 |
Pressure algometer/aesthesiometer, electronic |
Intended to measure the sensitivity to pain. |
A |
| 117 |
Rheoencephalograph |
A rheoencephalograph is a device used to estimate a patient's cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck area |
D |
| 118 |
Scalp clip |
A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp |
C |
| 119 |
Scoliosis-treatment electrical stimulation system |
Intended to apply electrical stimuli to the spinal musculature to produce a force that stabilizes or limits the progression of the spinal lateral curvature (i.e., scoliosis). |
D |
| 120 |
Skull plate anvil |
A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull |
A |
| 121 |
Skull punch |
A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means |
A |
| 122 |
Skullplate screwdriver |
A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws |
A |
| 123 |
Spinal needle bioimpedance navigation unit |
Intended to transmit and receive electrical signals to/from a dedicated spinal needle (which doubles as a bipolar electrode) and to analyze bioimpedance data in real-time, to predict needle tip location [including confirmation of contact with cerebrospinal fluid (CSF)]. |
C |
| 124 |
Stereotactic neuronavigation/planning system |
Intended to receive and analyze patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. |
C |
| 125 |
Stereotactic radiosurgical system |
Intended to deliver a therapeutic radiation dose to an anatomical region from external beams produced from multiple radionuclide sources arranged in a fixed focal point collimated array; typically used to treat brain, neck, breast and spinal tumors. |
D |
| 126 |
Tibial nerve percutaneous incontinence-control electrical stimulation system |
Intended to treat urinary and/or fecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS). |
D |
| 127 |
Transcranial electrical stimulation system, continuous-current and pulsed-current |
Intended for one or more psychiatric/neurological therapy types [e.g., transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS)]. And to induce a state resembling that of chemically-induced anesthesia for treating one or more psychiatric disorders which may include anxiety, depression, insomnia, and/or addiction. |
B |
| 128 |
Transvenous phrenic nerve electrical stimulation control unit |
Intended to configure/deliver stimulation of the phrenic nerve, via a transvenous electrode, to cause contraction of the diaphragm in conjunction with mechanical ventilation to assist earlier ventilation weaning. |
D |
| 129 |
Tuning fork |
Intended to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. |
A |
| 130 |
Ultrasonic scanner calibration test block |
An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph) |
A |
| 131 |
Vagus nerve electrical stimulation system programmer |
The strength and duration of the electrical impulses are programmed |
C |
| CATEGORY: Personal Protective Equipments |
|
|
|
| S.NO. |
Medical Device Name |
Intended Use |
INDIA |
| 1 |
Garment, Protective, For Incontinence |
Intended to protect an incontinent patient's garment from the patient's excreta. |
A |
| 2 |
Biosanitizer for Medical devices |
Intended for surface disinfection of medical devices, non-porous hard-surfaces, medical equipment, units, as well as in-depth cleaning of small surfaces. |
B |
| 3 |
Face shield |
Intended to protect the wearer's entire face (or part of it) from hazards such as chemical splashes (in laboratories or in industry), or potentially infectious materials (in medical and laboratory environments). |
A |
| 4 |
Particular respirator |
A disposable medical grade mask (respirator) is a safety device that covers the nose and mouth and helps protect the wearer from breathing in some hazardous or potentially infectious materials (in medical and laboratory environments). |
A |
| 5 |
Nitrile gloves |
Nitrile gloves intended to protect the patient and wearer and required to use where resistance to chemicals, including certain disinfectants such as chlorine is required. Also intended for patient and wearer allergic to natural rubber. |
B |
| 6 |
Latex surgical glove |
Natural rubber based glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery. |
B |
| 7 |
Non-latex surgical glove |
Synthetic material glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery. |
B |
| 8 |
Radiation protection gloves |
A personal protection device that completely protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. |
A |
| 9 |
Partial hand radiation protector |
A flat pad with straps or partial gloves that protect part of hands and fingers from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. |
A |
| 10 |
Radiation protection apron |
A standard length or half-length apron to protect the patient, the operator, and other personnel from radiation exposure during a medical or dental procedure. Some have a fixed or removable collar to protect the neck and thyroid. |
A |
| 11 |
Radiation protection mitten |
A personal protection device that protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. The mittens are also called mitts, and protect the thumb and other fingers individually or together. |
A |
| 12 |
Radiation protection goggles |
A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical/dental procedures for diagnosis and treatment. |
A |
| 13 |
Radiation face protector |
A transparent or opaque personal protection device that protects the face and eyes of medical personnel and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment. |
A |
| 14 |
Operator radiation protection spectacles |
A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment. The device comes in non-correction (non-prescription) glasses and visual acuity correction (prescription) glasses. |
A |
| 15 |
Gonadal radiation protector |
A personal protection device that attenuates unnecessary radiation exposure in diagnostic, medical or dental procedures, and shields the gonad of the patient and the operator. |
A |
| 16 |
Radiation protection blanket |
A personal protection device that protects specific body parts of the patient, operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment. |
A |
| 17 |
Radiation protection collar |
A personal protection device that protects the neck or thyroid of the patient, the operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment. |
A |
| 18 |
Radiation protection cap |
A personal protection device that protects the head of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical procedures for diagnosis and treatment. |
A |
| 19 |
Mobile radiation protection barrier |
A stand-alone, movable barrier that protects the operator etc. from unnecessary exposure to radiation used for medical diagnosis, treatment and dental procedures. |
A |
| 20 |
Non-latex medical examination glove |
Gloves made of synthetic materials, and used to protect the patient and users from cross infection during examination, check-up, treatment and handling of contaminated medical materials except for surgery. |
A |
| 21 |
Latex medical examination glove |
Natural rubber gloves used to protect the patient and users from cross infection during examination, check-up, treatment and handling of contaminated medical materials except for surgery. |
A |
| 22 |
Chemotherapy spill clean-up kit |
Designed to safely clean and dispose of Chemotherapy drug spills. |
B |
| 23 |
Gown/Coverall |
Intended to cover full body act as impermeable to blood and body fluids and ensure a high level of protection from biological/infectious agents. |
A |
| 24 |
Medical/Cadaver Body Bags |
Intended for transporting a human corpse without any spread of biohazard/infectious agent. |
B |
| CATEGORY: OBSTETRICAL AND GYNECOLOGICAL |
|
|
|
| S.NO. |
Device Name |
Intended Use |
INDIA |
| 1 |
Abdominal decompression chamber |
Non-invasive medical device placed at abdomen to alleviate abdominal pain during pregnancy or delivery. |
C |
| 2 |
Abdominal decompression chamber pump |
A dedicated pump used with hood-like device to control and reduce abdominal pressure of a pregnant women. |
C |
| 3 |
Abortion suction system manual aspirator |
A non-sterile, manual, syringe-like device to aspirate fluid from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation. Also used for endometrial biopsy. |
B |
| 4 |
Birthing bed/table, powered |
Bed used during labor and delivery. |
A |
| 5 |
Cardiotocograph |
A device that records fetal heart rate and uterine contraction simultaneously. |
C |
| 6 |
Cardiotocograph transducer |
A device that converts birthing contractions to electrical signals and is used together with cardiotocograph (CTG) which displays the signals. |
C |
| 7 |
Cardiotocography telemetric monitoring system |
An assembly of devices intended to be used to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals from a patient to a monitor. |
C |
| 8 |
Cardiotocography telemetric monitoring system receiver |
A part of wireless telemeter system. It receives signals from transmitter that senses fetal heart rate and uterine contraction during labor. |
C |
| 9 |
Cardiotocography telemetric monitoring system transmitter |
It transmits signals related to fetal heart rate and uterine contractions to the receiver. |
C |
| 10 |
Cervical anaesthesia kit |
For providing intercervical nerve block during gynaecological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. This is a single-use device. |
B |
| 11 |
Cervical anaesthesia needle, reusable or single use |
A sharp bevel-edged, hollow tubular metal instrument intended to be used to administer anaesthetic agent to function as an intracervical nerve-block. |
B |
| 12 |
Colposcope |
Special microscope for examination of female genital organs (e.g., vagina, cervix). |
B |
| 13 |
Contraceptive cervical cap, reusable or single use |
Device inserted into the cervix to prevent semen from entering the uterus. |
C |
| 14 |
Contraceptive spermicide |
A chemical substance (e.g., nonoxynol-9) intended to be introduced with an applicator or the finger into the vagina before sexual intercourse, to destroy sperm (spermatozoa) to prevent pregnancy. |
C |
| 15 |
Contraceptive sponge |
Bubble-like device works as a physical barrier to prevent spermatic invasion into uterus. |
C |
| 16 |
Diaphragm pessary |
A circular device placed in the vagina prior to intercourse to mechanically prevent conception. |
C |
| 17 |
Endocervical aspirator |
A collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction. |
B |
| 18 |
Endocervical specimen collection kit, no additive |
Sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix for culture, analysis, and/or other investigation. |
B |
| 19 |
Endometrial biopsy curette |
Surgical instrument used for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. |
B |
| 20 |
Endometrial biopsy kit |
For the collection of a tissue sample taken from the lining of the uterus (endometrium). |
B |
| 21 |
Endometrial cytology brush |
A brush used to collect mucosal cells for pathological diagnosis during endoscopic examination. |
B |
| 22 |
Fallopian tube biopsy everting-balloon catheter |
A sterile device intended to be inserted through a hysteroscope to obtain biopsy samples from a fallopian tube for cytological examination. |
B |
| 23 |
Fallopian tube catheterization kit |
A collection of sterile devices for the transuterine catheterization of the fallopian tubes to inject dye or contrast medium for the evaluation of tubal patency. |
B |
| 24 |
Fallopian tube insufflator |
Active invasive device designed to insufflate the Fallopian tubes with a gas [typically carbon dioxide (CO2)] to maintain tubal patency for a procedure. |
B |
| 25 |
Fallopian tube occlusion insert |
Contraceptive implantable device implanted into the uterine end of the fallopian tubes to function as a contraceptive by obstructing the natural fallopian tube passage. |
D |
| 26 |
Fixed-diameter cervical dilator, reusable or single use |
To dilate the cervical canal with a balloon when the uterus does not dilate enough due to inertia uteri. |
B |
| 27 |
Flexible fibreoptic culdoscope |
Flexible endoscope for the visual examination, diagnosis, and treatment of the urinary bladder and urethra. |
B |
| 28 |
Flexible fibreoptic hysteroscope |
For the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). |
B |
| 29 |
Flexible fibreoptic laparoscope |
For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. |
B |
| 30 |
Flexible fibreoptic mammary ductoscope |
For the visual examination and treatment of the mammary duct. |
B |
| 31 |
Flexible fibreoptic salpingoscope |
For the visual examination and treatment of the fallopian tubes (oviducts). |
B |
| 32 |
Flexible ultrasound laparoscope |
For the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. |
B |
| 33 |
Flexible video culdoscope |
For the visual examination and treatment of the female peritoneal cavity and organs. |
B |
| 34 |
Flexible video hysteroscope |
For the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). |
B |
| 35 |
Flexible video laparoscope |
For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. |
B |
| 36 |
Flexible video mammary ductoscope |
For the visual examination and treatment of the mammary duct. |
B |
| 37 |
Flexible video salpingoscope |
For the visual examination and treatment of the fallopian tubes (oviducts). |
B |
| 38 |
Foetal acoustic stimulator |
Uses sound stimuli to assess foetal well-being. This device is used to evaluate the status of the foetus as expressed by, e.g., foetal heart rate changes or foetal acid-base status, in antepartum tests and/or during intrapartum monitoring. |
B |
| 39 |
Foetal bladder shunt |
A sterile non-bioabsorbable tubular device implanted in the bladder of a foetus with postvesicular obstructive uropathy, to decompress the urinary tract for urine to pass from bladder into the amniotic sac, until the defect can be surgically repaired after birth. |
C |
| 40 |
Foetal blood sampler |
Invasive device to collect fetal blood through the uterine cervix. |
B |
| 41 |
Foetal cardiac monitor |
Active device designed to detect, measure, and display foetal heart activity during the perinatal period. |
C |
| 42 |
Foetal pleuro-amniotic catheter |
Sterile implantable device used to continuously drain fetal pleural effusion into the maternal amniotic cavity. |
C |
| 43 |
Foetal scalp electrode, clip |
Placed directly on the scalp of the fetus in the uterus to monitor fetal vital signs. |
C |
| 44 |
Foetal stethoscope |
Mechanical hearing device used to listen to fetal heartbeat. |
A |
| 45 |
Foetal vacuum extraction cup, reusable or single use |
A device used to extract the head of the fetus with a vacuum cup. |
B |
| 46 |
Foetal vacuum extraction system monitor |
A battery-powered vacuum measuring device that is connected via tubing to the suction line of a foetal vacuum extracting cup, to measure and record data related to a vacuum-assisted delivery such as the level of vacuum applied, the number and duration of pulls, and number of pop-offs. |
B |
| 47 |
Foetal vacuum extraction system, manual, reusable or single use |
To facilitate the delivery of a foetus during vaginal childbirth or Caesarean. |
B |
| 48 |
Foetal vacuum extraction system, pneumatic |
To facilitate the delivery of a foetus during vaginal childbirth or Caesarean. |
B |
| 49 |
Foetal/maternal multiple physiological parameter simulation kit |
To imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers. |
B |
| 50 |
Foetal/maternal multiple physiological parameter simulator |
To imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers. |
B |
| 51 |
Gynaecological bib |
A piece of cloth worn by the patient. |
A |
| 52 |
Gynaecological examination/treatment table, manual |
To support a woman's body in the appropriate positions during gynaecological examinations. |
A |
| 53 |
Gynaecological operating table top |
A component of a modular operating table designed as a detachable table top constructed for gynaecological surgical procedures. |
A |
| 54 |
Gynaecological operating table, electrohydraulic or electromechanical or hydraulic |
Active device designed to support a patient during gynaecological surgical procedures. |
A |
| 55 |
Gynaecological scissors, reusable or single use |
To cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. |
B |
| 56 |
Gynaecological surgical microscope |
To improve visualization of anatomical structures via transmitted light during gynaecological surgery (e.g., on the fallopian tubes). |
B |
| 57 |
Heel stirrup |
A device used during a medical/surgical procedure to steadily hold a patient's foot (feet) by cradling the heel or the whole foot. |
A |
| 58 |
Hysteroscopic insufflator |
A device that sends gas into the fallopian tube to maintain the patency of the tubes. |
B |
| 59 |
Hysteroscopic irrigation/insufflation system |
Used during endoscopic procedures of the uterus to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization and enlarge the surgical field. It also circulates the fluid to provide irrigation that will remove tissue/debris from the site. |
B |
| 60 |
Intrauterine cannula, reusable or single use |
To aspirate fluid/material from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation; it may also be intended for endometrial biopsy. |
B |
| 61 |
Intrauterine haemostatic balloon catheter |
A sterile, flexible tube with an inflatable balloon inserted into the uterus and distended with a medium (e.g., sterile water, medical air or other appropriate gas) to reduce postpartum bleeding with pressure. |
B |
| 62 |
Intrauterine haemostatic suction catheter |
Inserted into the uterus to reduce postpartum bleeding through aspiration of blood/debris and induction of uterine contractions. |
B |
| 63 |
Intrauterine imaging medium catheter |
Intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus. |
B |
| 64 |
Intrauterine imaging medium catheterization kit |
Sterile devices intended for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus. |
B |
| 65 |
Laparoscope laser coupler or laser/laparoscope adaptor |
To connect the laparoscope to the laser or the laser arm for laparoscopic laser treatment. |
B |
| 66 |
Laparoscope system, reprocessed |
For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). |
B |
| 67 |
Laparoscope system, reusable or single use |
For the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). |
B |
| 68 |
Manual expandable cervical dilator |
To dilate the cervical canal with a balloon when the uterine does not dilate enough due to inertia uteri. |
B |
| 69 |
Massage oil/cream/gel |
Applied to the skin and/or external mucosa to facilitate therapeutic massage. |
A |
| 70 |
Mechanical foetal heart simulator |
To imitate a foetal heart (e.g., foetal heart ultrasound signals) when used in combination with a foetal/maternal multiple physiological parameter simulator in order to test foetal monitoring and recording equipment [e.g., cardiotocograph (CTG)], check patient cable continuity, or to train healthcare providers. |
B |
| 71 |
Menstrual cup, Hevea-latex |
Placed in the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. |
B |
| 72 |
Menstrual cup, non-latex, reusable or single use |
Placed in the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. |
B |
| 73 |
Menstrual tampon, scented or unscented |
Inserted into the vagina to absorb menstrual or other vaginal discharge. |
B |
| 74 |
Motorized laparoscopic forceps |
Active surgical instrument designed for grasping, mobilizing, and suturing tissues/vessels under direct or endoscopic visualization during a surgical procedure. |
B |
| 75 |
Papanicolaou smear kit or Endometrial sampling kit |
Used to collect and prepare pap smear samples in a medical institute. |
B |
| 76 |
Pelvic examination kit |
For performing pelvic examination. |
B |
| 77 |
Pelvimeter |
A measuring device used to determine the pelvic dimensions. |
B |
| 78 |
Pelviscope |
An endoscope used for visual examination and diagnosis of pelvis. |
B |
| 79 |
Perineal warmer |
It is useful for pain relief in the vulva after episiotomy. |
B |
| 80 |
Perineometer |
To determine perineal muscle strength through resistance to spontaneous contraction of perineal muscle. Also used to diagnose and treat urinary incontinence and sexual dysfunction through movement. |
B |
| 81 |
Pudendal anaesthesia kit |
A collection of sterile devices designed to deliver anaesthetic agent to the external genitalia of humans. |
B |
| 82 |
Resectoscope |
An endoscope used for visual examination, diagnosis and treatment, especially for resection, of tissues. |
B |
| 83 |
Rigid culdoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the female peritoneal cavity and organs. |
B |
| 84 |
Rigid fibreoptic hysteroscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). |
B |
| 85 |
Rigid mammary ductoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the mammary duct. |
B |
| 86 |
Rigid optical laparoscope |
An endoscope with a rigid inserted portion for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. |
B |
| 87 |
Rigid salpingoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the fallopian tubes (oviducts). |
B |
| 88 |
Rigid ultrasound laparoscope |
An endoscope with a rigid inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. |
B |
| 89 |
Rigid video hysteroscope |
Active device intended to allow visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). |
B |
| 90 |
Rigid video laparoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. |
B |
| 91 |
Suprapubic needle, surgical, reusable or single use |
Percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair. |
B |
| 92 |
Umbilical ligator |
Surgical device used for umbilical cord ligation. |
A |
| 93 |
Uterine injector |
Used to inject liquid, drug, or other substance into uterus. It is a reusable device. |
B |
| 94 |
Uterine manipulator cervical cup/transilluminator |
Allow manipulation of the uterus under suction whilst preventing laparoscopic insufflation gas from escaping from the cervix (during hysterectomy). |
B |
| 95 |
Uterine manipulator, reusable or single use |
Surgical instrument designed to mechanically manipulate the position of the uterus during a gynaecological intervention. |
B |
| 96 |
Uterine packer |
A hand-held, surgical instrument used to introduce dressings into the uterus or vagina. This is a reusable device. |
B |
| 97 |
Uterine probe |
For exploring the uterus during a surgical procedure. Used as a component of a uterine manipulator. |
B |
| 98 |
Uterus-supporting pessary |
Inserted into the vagina to hold the uterus in place. |
B |
| 99 |
Vaginal applicator, reusable or single use |
A device designed to apply medication to the vagina. |
A |
| 100 |
Vaginal dilator |
Inserted into the vagina to dilate a narrow vaginal opening due to congenital defect. Can be used during examination, treatment or surgical procedure. |
B |
| 101 |
Vaginal douche, reusable or single use |
To deliver a liquid (usually solution) directly into the vaginal cavity for hygienic purpose as a douche. |
B |
| 102 |
Vaginal douching fluid tablet |
A tablet containing various compounds (e.g., sodium bicarbonate, citric acid, aloe barbadensis powder) designed to be dissolved in a vaginal douche. |
B |
| 103 |
Vaginal lubricant |
To lubricate the vagina to facilitate entry of a gloved finger(s) or a device (e.g., a vaginal speculum) during a diagnostic or therapeutic procedure. |
A |
| 104 |
Vaginometer |
A device that measures the length and diameter of vagina. |
A |
| 105 |
Vaginoscope |
For pediatric vaginal examination. To search foreign matter or bleeding site. |
B |
| 106 |
Viscera retention paddle or Visceral retainer |
Used to hold an organ at proper position (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is also implanted into a surgical site temporarily. |
B |
| 107 |
Breast transilluminator |
Active device transmitted through the female breast to visualize translucent tissue for the diagnosis of cancer, or other conditions, diseases or abnormalities. |
C |
| 108 |
Amniotic membrane perforator, reusable |
A surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus. |
A |
| 109 |
Amniotome, reusable |
A surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus. |
B |
| 110 |
Birthing/delivery kit |
A collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. |
A |
| 111 |
Bladder-supporting pessary |
Inserted into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse. |
B |
| 112 |
Catheter-tip transducer, pressure |
A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. |
B |
| 113 |
Foetal Doppler system |
Active non-invasive device to detect foetal heart beats using ultrasound/Doppler technology. |
B |
| 114 |
Foetal Doppler system probe |
Placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. |
B |
| 115 |
Menstrual pad, scented |
Held in place externally to absorb menstrual or other vaginal discharge. |
B |
| 116 |
Menstrual pad, unscented |
Held in place externally to absorb menstrual or other vaginal discharge. |
A |
| CATEGORY: Ophtalmic Medical Devices |
|
|
|
| S.NO. |
Device Name |
Intended Use |
Classification-IMDR |
| 1 |
Adaptometer |
An ophthalmic device intended to measure the time required for retinal adaptation and the minimum light threshold. |
B |
| 2 |
Amsler grid |
An ophthalmic device intended to rapidly detect central and paracentral irregularities in the visual field. |
A |
| 3 |
Anomaloscope |
An ophthalmic instrument used to test a patient for abnormal red/green colour vision by differentiating the red/green colour vision defects. |
A |
| 4 |
Aqueous/vitreous humour replacement medium kit |
A collection of sterile devices, including a fluid or semifluid substance, used in combination to replace the fluid of the eye. |
D |
| 5 |
Automated lensmeter(Dioptometer) |
An ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism. |
A |
| 6 |
Bagolini lens |
An ophthalmic plane lens, intended to determine harmonious/anomalous retinal correspondence. |
A |
| 7 |
Binocular vision test unit |
An ophthalmic device for binocular vision testing. |
A |
| 8 |
Blepharoplasty scissors |
A hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty). |
A |
| 9 |
Capsular bag anchor |
A device intended to be permanently implanted in the posterior chamber of the eye for correction and fixation of a subluxated capsular bag, typically in association with in-the-bag intraocular lens (IOL) implantation. |
C |
| 10 |
Colour discrimination spectacle lens |
An ophthalmic lens intended to be worn infringement of the eyes to correct refractive vision conditions and that is coloured/tinted to enhance colour discrimination in patients with colour vision deficiency. |
A |
| 11 |
Colour discrimination tester |
An ophthalmic lamp, used to test a person's ability to differentiate between colours. |
A |
| 12 |
Colour-discrimination eye chart |
Intended for testing colour vision. |
A |
| 13 |
Conjunctival scissors |
A hand-held, manual, ophthalmic surgical instrument intended to be used to cut the conjunctiva and Tenon’s capsule on the eye surface to access the sclera. |
A |
| 14 |
Contact Lens |
Device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. |
B |
| 15 |
Contact lens agitation cleaning system |
An assembly of devices used to clean and disinfect contact lenses through automated or manual mechanical agitation. |
C |
| 16 |
Contact lens disinfecting solution |
An aqueous formulation containing appropriate agents for loosening debris from contact lenses, and that contains a disinfectant intended to act on contact lens. |
C |
| 17 |
Contact lens protein-removal solution |
A formulation of proteolytic enzymes, used to remove debris and protein deposits from reusable contact lenses, or to remove protein deposits only. |
C |
| 18 |
Contact lens radius gauge |
A measuring instrument used in ophthalmology to determine the radius of curvature of contact lenses. |
A |
| 19 |
Contact lens thermal cleaner |
A unit intended to disinfect or sterilize reusable soft contact lenses by means of heat. |
C |
| 20 |
Corneal burr manual instrument |
A hand-held, ophthalmic surgical instrument, used to excavate corneal tissue through manual rotation. |
B |
| 21 |
Corneal burr system |
An assembly of devices designed for abrasion of the cornea and other eye tissues. |
B |
| 22 |
Corneal burr, abrasion |
A device designed for abrasion of the cornea to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions. |
B |
| 23 |
Corneal burr, rust ring removal |
A device designed for gentle removal of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object. |
B |
| 24 |
Corneal epithelium perforator |
Intended to create a number of small perforations in the epithelial layer of the cornea through which riboflavin can pass into the cornea during corneal collagen crosslinking, to treat corneal ectasia (typically keratoconus). |
B |
| 25 |
Corneal epithelium trephine |
Intended to create a circular cut through the epithelial layer of the cornea to create an epithelial flap intended to be folded back during laser assisted epithelial keratomileusis (LASEK) surgery, after which the flap is replaced. |
B |
| 26 |
Corneal inlay, aperture reducing |
An implantable device inserted into the natural cornea to treat presbyopia based on aperture reduction. |
C |
| 27 |
Corneal inlay, corneareshaping |
An implantable device inserted into the natural cornea to treat refractive errors by reshaping the cornea. |
C |
| 28 |
Corneal light shield |
A device, typically made of a non-abrasive fluid-absorbing material that is placed on the surface of the cornea to shield the retina from excessive illumination during an ophthalmic procedure. |
B |
| 29 |
Corneal marker |
A manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. |
B |
| 30 |
Corneal resection holder |
A device designed to hold donated corneal tissue so that it can be resected in preparation for transplantation. |
B |
| 31 |
Corneal scissors |
A hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue. |
B |
| 32 |
Corneal shield |
A mechanical eye shield made of collagen that is placed on the eye to protect the cornea. |
B |
| 33 |
Corneoscleral punch |
A hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue from the sclera or cornea of a patient or from grafts taken from cadaver donors. |
B |
| 34 |
Diagnostic condensing lens |
An ophthalmic lens used in binocular indirect ophthalmoscopy to focus reflected light from the fundus of the eye. |
A |
| 35 |
Donor cornea container |
A receptacle intended to maintain, transport, and facilitate clinical examination of a donated cornea during the period between cornea collection and transplantation surgery. |
C |
| 36 |
Eikonometer |
An ophthalmic instrument for diagnosing aniseikonia. |
A |
| 37 |
Electronic occlusion spectacles |
An ophthalmic device designed to test and train vision for conditions where decreased visual acuity may be due to unequal vision in the eyes. |
A |
| 38 |
Endoscopic-imaging ophthalmic solid-state laser system |
A device assembly intended to treat retinal and other eye disorders, such as glaucoma, during endoscopic cyclophotocoagulation (ECP) procedures. |
C |
| 39 |
Enucleation scissors |
A hand-held, manual, ophthalmic surgical instrument used to cut tissue during eye surgery involving enucleation of the eye and/or its related structures. |
A |
| 40 |
Epiretinal/inner limiting membrane scraper |
A hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. |
B |
| 41 |
Euthyscope |
A modified ophthalmoscope that projects a bright light encompassing an arc of approximately 30 degrees on the fundus of the eye for the treatment of amblyopia. |
B |
| 42 |
Exophthalmometer |
An ophthalmic instrument used to measure the degree of exophthalmos. |
A |
| 43 |
Eye cup |
A receptacle designed to fit around the eye socket and which is filled with warm water or an eyewash solution and placed over the eye to allow the liquid to wash the affected eye. |
B |
| 44 |
Eye heat therapy pack |
A device intended to be placed over closed eyes to apply heat for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis and other related ocular conditions. |
B |
| 45 |
Eye irrigation shield |
A device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye. |
A |
| 46 |
Eye muscle clamp |
An hand-held manual ophthalmic surgical instrument designed to atraumatically grasp and hold the extraocular muscles (EOM) during an ophthalmic surgical intervention. |
B |
| 47 |
Eye muscle sleeve |
An implantable device made from synthetic materials that is used to encase or isolate an ocular muscle. |
C |
| 48 |
Eye pad |
A sterile, cushion-like device intended to protect the eye or to absorb eye secretions. |
A |
| 49 |
Eye spud |
A hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. |
A |
| 50 |
Eye valve |
An implantable device designed to regulate the flow of fluid between the anterior chamber and the space around the conjunctiva of the eye by allowing flow when the pressure in the chamber is above a pre-set value. |
C |
| 51 |
Eyelid clamp |
A hand-held manual surgical instrument designed to atraumatically grasp and hold the eyelid during an ophthalmic surgical intervention. |
A |
| 52 |
Eyelid weight, external |
An ophthalmic device that is applied to the outside of the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle function. |
A |
| 53 |
Eyelid weight, implantable |
An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle function. |
C |
| 54 |
Felt tangent screen |
A black tangent screen intended for assessing the extent of the patient's peripheral visual field by mapping the visual response to a test object moved from the periphery towards the centre of the screen. |
A |
| 55 |
Femtosecond ophthalmic solidstate laser system |
A device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions. |
C |
| 56 |
Fibreoptic general-purpose ophthalmic hook |
A hand-held manual surgical instrument inserted into the eye during surgical intervention to manipulate anatomical structures or foreign bodies within the eye and simultaneously conduct a field of cold light to illuminate the surgical site. |
A |
| 57 |
Flieringa ophthalmic ring |
A circular band, sutured to the sclera to prevent collapse of the globe during difficult intraocular operations. |
B |
| 58 |
Fornixscope |
A manually-operated, ophthalmic device intended to provide indirect access and viewing of the upper conjunctival fornix and inner surface of the eyelid as an alternative to eyelid eversion. |
A |
| 59 |
Fresnel lens |
A very thin and flexible ophthalmic lens intended to be applied to the back of spectacle lenses to focus light to a focal point to help manage various vision conditions. |
A |
| 60 |
Fresnel prism |
A device intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction. |
A |
| 61 |
Fundus-imaging ophthalmic diode laser system |
Intended for ocular laser treatment procedures, including coagulation of abnormal retinal vasculature; and capturing real-time digital images of the anterior/posterior eye segments created using colour, fluorescein angiography and infrared imaging, for diagnosis/treatment planning. |
C |
| 62 |
Fundus-imaging ophthalmic solid-state laser system |
Intended to coagulate abnormal vascular tissue in the retina and for other ocular photocoagulation procedures. |
C |
| 63 |
Glaucoma supraciliary implant |
A non-bioabsorbable synthetic polymer device designed to be implanted in the supraciliary space (between the ciliary muscle/body and the sclera) for the restoration of aqueous humour outflow and subsequent reduction of intraocular pressure as part of treatment for open angle glaucoma. |
C |
| 64 |
Glaucoma therapy ultrasound system |
A system designed to transduce radio-frequency (RF) electrical energy from a generator into ultrasound energy, for the extracorporeal application of high intensity focused ultrasound (HIFU) to the eye, to decrease aqueous humour production and reduce intraocular pressure (IOP). |
C |
| 65 |
Haidinger brush imager |
An ophthalmic device designed to produce an image which facilitates his/her visual function evaluation, particularly the macular integrity. |
A |
| 66 |
Hand-held campimeter |
A portable, hand-held device intended for assessing the central 30º visual field. |
A |
| 67 |
Hand-held telescope |
A device that consists of an arrangement of ophthalmic lenses or mirrors with a handle intended to enlarge images for a visually impaired patient/person. |
A |
| 68 |
Hruby fundus lens |
A 55 dioptre non-contact diagnostic ophthalmic lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification. |
A |
| 69 |
Implantable intraocular pressure monitoring system |
An assembly of portable devices intended to continuously or regularly collect and display intraocular pressure (IOP) data for the diagnosis/monitoring of glaucoma. |
C |
| 70 |
Implantable iris prosthesis |
An optical device intended to be implanted into the posterior chamber of the eye for the reconstruction of partial or total iris defects. |
C |
| 71 |
Indirect binocular ophthalmoscope |
An ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. |
A |
| 72 |
Intracorneal ring |
An implantable, open-ended circular band designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct mild and moderate myopia. |
C |
| 73 |
Intranasal lacrimal neurostimulator |
A hand-held device intended to be used in the home to provide electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye. |
C |
| 74 |
Intraocular pressure-reducing system |
An assembly of manually-operated devices designed to reduce the intraocular pressure (IOP) by applying a controlled, external, mechanical compression to the surface of the eye in preparation for ophthalmic surgery. |
C |
| 75 |
Keratome |
An ophthalmic surgical instrument intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. |
B |
| 76 |
Lacrimal tube |
An implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, and also to facilitate saline solution irrigation to a paranasal sinus to manage chronic rhinosinusitis. |
B |
| 77 |
Lens spoon |
A hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye. |
A |
| 78 |
Maddox trial lens |
A special ophthalmic trial lens in the form of a rod or series of rods (grooves/cylinders) that changes the size, shape, and colour of an image to dissociate the eyes in the evaluation of eye muscle dysfunction. |
A |
| 79 |
Mirror-prism spectacles |
An optical device intended to enable the patient to see over the top of their head enabling them to look forward in the direction their head is pointing. |
A |
| 80 |
Nystagmus inducing optokinetic drum |
An ophthalmic device intended to elicit nystagmus. |
A |
| 81 |
Nystagmus inducing tape |
An ophthalmic device intended to be moved across a patient's field of vision to elicit optokinetic nystagmus and to test for blindness. |
A |
| 82 |
Ocular occluder |
An hand-operated ophthalmic device typically used by an optician/optometrist to temporarily prevent or attenuate (occlude) the passage of light (vision) to one eye, during examination and testing of a patient's eyesight in the opposite eye. |
A |
| 83 |
Ophthalmic calliper |
A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. |
A |
| 84 |
Ophthalmic clip |
A device typically made of a malleable metal (e.g., tantalum), intended to be implanted permanently or temporarily to bring together the edges of a wound, to aid in healing or to prevent bleeding from small blood vessels in the eye. |
C |
| 85 |
Ophthalmic cryosurgical system |
An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) to a target tissue for its destruction and removal during an ophthalmic surgical procedure. |
C |
| 86 |
Ophthalmic distometer |
An ophthalmic instrument designed to measure the distance between the cornea and a spectacle or trial lens (vertex distance). |
A |
| 87 |
Ophthalmic dye laser system |
A laser device assembly intended to coagulate abnormal vascular tissue in the retina, and for other photocoagulation procedures in the eye. |
C |
| 88 |
Ophthalmic examination station |
A device assembly intended to provide complete ophthalmic examination position and support conditions for the patient and clinician. |
A |
| 89 |
Ophthalmic excimer laser system |
A laser device assembly intended for corneal ablation and other ophthalmologic procedures. |
C |
| 90 |
Ophthalmic head reflector |
A head-worn ophthalmic device intended to reflect light onto the eye of a patient to allow examination of the eye and its associated structures. |
A |
| 91 |
Ophthalmic instrument table |
A device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments for the examination/treatment of a patient's eyes. |
A |
| 92 |
Ophthalmic noble gas laser system |
A laser device assembly intended to coagulate abnormal vascular tissue in the retina and for other photocoagulation procedures in the eye. |
C |
| 93 |
Ophthalmic operating table top |
A component of a modular operating table intended to provide support for and stabilization of the head of the patient (typically includes a headrest) and to help provide optimal access for the surgeon(s) during the intervention (e.g., by having a small-width table top and therefore a shorter stretch distance for the surgeon). |
B |
| 94 |
Ophthalmic soft-tissue surgical forceps |
A hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). |
B |
| 95 |
Ophthalmic surgical device handling forceps |
A hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. |
A |
| 96 |
Ophthalmic suture scissors |
A hand-held, manual, ophthalmic surgical instrument intended to be used to cut suture during eye surgery. |
A |
| 97 |
Ophthalmic tonometer |
An ophthalmic, measuring instrument designed for determining the intraocular pressure (IOP). |
B |
| 98 |
Ophthalmic ultrasound imaging system |
An assembly of devices designed for ophthalmic ultrasound imaging procedures. |
B |
| 99 |
Ophthalmodiastimeter |
An ophthalmic instrument for determining the proper distance at which to place prescription lenses for the two eyes. |
A |
| 100 |
Ophthalmoleukoscope |
An ophthalmic device intended to be used for testing colour perception by means of colours produced by polarized light. |
A |
| 101 |
Ophthalmoscope |
An ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media. |
C |
| 102 |
Optical pachymeter |
An ophthalmic, device that uses optics to measure the thickness of the cornea. |
A |
| 103 |
Orbital depressor |
A hand-held ophthalmic surgical instrument used to displace tissue to facilitate examination of the surrounding area in the orbital cavity during eye surgery. |
A |
| 104 |
Orbital rim prosthesis |
An implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its associated muscles, vessels, and nerves and is intended to house an artificial eye. |
C |
| 105 |
Perimeter |
A diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. |
A |
| 106 |
Periocular/lacrimal retractor |
A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention. |
A |
| 107 |
Phacoemulsification system |
An assembly of ophthalmic devices intended to deliver energy through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification. |
C |
| 108 |
Phorometer |
An ophthalmic instrument intended to be used to test ocular balance. |
A |
| 109 |
Phoropter |
A mechanical ophthalmic device that is used during an ophthalmic examination; typically to determine a patient's prescription for glasses. |
A |
| 110 |
Pleoptophor |
An ophthalmic instrument used for the treatment of eccentric eye fixation (casts in the eye) by dazzling the perimacular retina, thereby relatively enhancing the visual capabilities of the fovea. |
A |
| 111 |
Polatest |
An ophthalmic device used for evaluating hidden (latent) squinting, i.e., when the patient is not aware of the condition, and also when it cannot be seen. |
A |
| 112 |
Ptosis crutch |
A device that is attachment to an ophthalmic spectacle frame to prop open the upper eyelid in cases of ptosis. |
A |
| 113 |
Ptosis sling |
A sterile implantable device intended for the surgical correction of ptosis. |
C |
| 114 |
Pupillograph |
A graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes. |
A |
| 115 |
Pupillometer |
An ophthalmic instrument used for measuring the width or diameter of the pupil. |
A |
| 116 |
Recumbent spectacles |
An optical/ophthalmic device that consists of prismatic lenses that is worn in front of the user's eyes to angle the field of vision enabling the user to read or watch television whilst lying in a supine position. |
A |
| 117 |
Retinal tack |
A non-bioabsorbable, implantable device designed to permanently fix a detached retina to the underlying retinal pigment epithelium (RPE) during ophthalmic surgery. |
C |
| 118 |
Scleral buckling device |
A device intended to be implanted on the sclera to compress the eye (scleral buckling) for the surgical treatment of retinal detachment. |
C |
| 119 |
Scleral expansion implant |
A device designed for implantation in the sclera to produce expansion by altering the position of the underlying ciliary muscle. |
C |
| 120 |
Scleral marker |
A manual instrument used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. |
B |
| 121 |
Sclerotome |
A hand-held manual ophthalmic surgical instrument that is knife-like in design and intended to be used to incise the sclera during a sclerotomy. |
A |
| 122 |
Scotometer |
An instrument used for the recording and measuring of the areas of field of vision that is reduced, i.e., relative scotoma, or loss of sensitivity to light (absolute scotoma or blind spots). |
A |
| 123 |
Spectacle frame |
An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. |
A |
| 124 |
Spectacle lens |
An ophthalmic device used to correct the refractive errors of that patient's eyesight and possibly to protect the eyes against radiation or mechanical hazards. |
A |
| 125 |
Spectacle lens curvature gauge |
An ophthalmic instrument designed to manually measure the curvature of the surface of a spectacle lens. |
A |
| 126 |
Spectacle-mounted telescope |
A device that consists of an arrangement of ophthalmic lenses or mirrors designed to be attached to a pair of spectacles and intended to enlarge images for a visually impaired patient/person. |
A |
| 127 |
Spectacles |
An ophthalmic device that are worn in front of the user's eyes to improve their ability to see normally. |
A |
| 128 |
Surgical binoculars |
A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. |
A |
| 129 |
Symblepharon ring |
An implantable device formed as a circular band used to help prevent the eyelid from adhering to the eyeball. |
C |
| 130 |
Synoptophor |
An ophthalmic device used for the evaluation and training of a patient's binocular function. |
A |
| 131 |
Tachistoscope |
An ophthalmic device designed to flash words or images at different speeds, for the purposes of ophthalmic diagnostic testing. |
A |
| 132 |
Tinted spectacle lens |
An ophthalmic device used to correct the refractive errors of that patient's eyesight and to attenuate light radiation by absorption, reflection, or polarization. |
A |
| 133 |
Tinted spectacles |
An optical device that contains a pair of tinted spectacle lenses that are worn in front of the user's eyes to correct the refractive errors of that patient's eyesight and to attenuate light radiation by absorption, reflection, or polarization. |
A |
| 134 |
Trial lens |
An individual ophthalmic lens from a trial lens set. |
A |
| 135 |
Trial lens clip |
A device used to hold prisms, spheres, cylinders, or occluders on a trial lens frame or set of spectacles during vision testing. |
A |
| 136 |
Trial lens frame |
A device used in ophthalmic work for placing, holding, and exchanging trial lenses in front of the eyes of the patient during a sight-testing procedure. |
A |
| 137 |
Trial lens set |
A set of ophthalmic trial lenses of various dioptric powers intended for vision testing to determine the required refraction. |
A |
| 138 |
Ultrasound pachymeter |
An ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth. |
B |
| 139 |
Visual chart |
An ophthalmic chart (Snellen chart) used in testing visual acuity. |
A |
| 140 |
Visual light box |
A light viewing box that uses a translucent version of the ophthalmic chart (Snellen chart) used for testing visual acuity. |
A |
| 141 |
Visual projector |
An ophthalmic device intended to project an image on a screen to test visual acuity. |
A |
| 142 |
Visual evoked-potential electrode |
An electrical conductor intended to record changes in the electrical potential for the purpose of measuring visual evoked responses. |
A |
| 143 |
Vitrectomy system |
An assembly of ophthalmic devices intended to deliver energy through a dedicated hand-held instrument, typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole. |
C |
| 144 |
Vitreous body prosthesis |
A sterile bag/capsule intended to be implanted in the eye and filled with a fluid (not included) to replace the vitreous body and provide omnidirectional support of the retina for the treatment of severe retinal detachment. |
C |
| CATEGORY: Rehabilitation and physical support |
|
|
|
| S.NO. |
Name of Medical Device |
Intended Use |
Classification India as per First Schedule part- 1 MDR 2017 |
| 1 |
Acupressure calf band |
Intended to wear around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome. A non-powered belt-like device. |
A |
| 2 |
Arthritis TENS system |
Intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). |
B |
| 3 |
Back pulldown exerciser |
Intended to strengthen the muscles of the back (especially the latissimus dorsi) through a repetitive pulldown motion performed with the arms against the force of a weight. |
A |
| 4 |
Back row exerciser |
Intended to strengthen the muscles of the back through a repetitive rowing motion (as in rowing a boat with oars) performed with the arms against the force of a weight. |
A |
| 5 |
Back/leg/chest dynamometer, electronic |
Powered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. |
B |
| 6 |
Back/leg/chest dynamometer, mechanical |
Non-powered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. |
A |
| 7 |
Balance ball exerciser |
Intended to be used as an unstable surface on which to perform exercise to improve balance and posture. |
A |
| 8 |
Balance-training tongue electrical stimulation system |
Intended to provide biofeedback for training of balance by sensing body movements and subsequently producing signals which are translated into electrical stimuli applied to the tongue, enabling a patient to correlate electrotactile stimulation with their head and body position during exercise sessions. |
B |
| 9 |
Bed/chair electric massager |
Intended to provide therapeutic massage to the occupant of a bed or chair for the treatment of body aches and pains. |
B |
| 10 |
Bicycle ergometer |
Intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. |
A |
| 11 |
Bladder-emptying vibratory stimulator |
Intended to initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. |
B |
| 12 |
Blue/red/infrared phototherapy lamp |
Intended to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). |
A |
| 13 |
Body elastic exerciser |
Intended to primarily strengthen several or all of the major muscle groups of the body (i.e., in the arms, legs, chest, back, and/or abdomen) through repetitive body motion against elastic resistance. |
A |
| 14 |
Body flywheel exerciser |
Intended to strengthen several of the major muscle groups of the body (i.e., in the arms, legs, chest, back) through repetitive body motion against a flywheel. |
A |
| 15 |
Circulating-fluid thermal therapy system |
Intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). |
B |
| 16 |
Cold compression therapy cervical spine collar |
Intended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation, stiffness, whiplash). |
A |
| 17 |
Cold/cool therapy gel |
Intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling. |
A |
| 18 |
Cold-air therapy unit |
Intended to reduce localized pain/inflammation, and/or to reduce thermal skin damage by applying cold stream of air during dermatological laser treatments. |
B |
| 19 |
Core-body mechanical weight exerciser |
Intended to enable a patient with a lumbar spine injury to perform controlled extension, contraction, and/or twisting movements of the lumbar/thoracic spine back region and the abdomen, for testing and rehabilitation. |
A |
| 20 |
Deep-tissue electromagnetic stimulation system |
Intended to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of therapeutic deep heat. |
B |
| 21 |
Electric massager |
Intended for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility. |
B |
| 22 |
Electromechanical orthopaedic extracorporeal shock wave therapy system |
Intended to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. |
C |
| 23 |
Electronic goniometer/kinesiology sensor |
Intended to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess the degree of physical fitness. |
B |
| 24 |
Exothermic heat therapy pack |
Intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. |
A |
| 25 |
Finger/hand exerciser |
Intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity or density. |
A |
| 26 |
Foot sensorimotor therapy mechanical neurostimulator |
Intended to provide noninvasive peripheral neurostimulation to the feet for improving somatosensory integration, typically for reducing motor impairments and balance disturbances in patients with neurological or neurodegenerative disorders (e.g., Parkinson's disease). |
C |
| 27 |
Gait analysis system |
Intended to be used to study walking or running patterns. |
A |
| 28 |
Hand dynamometer/pinchmeter, electronic |
Electronic device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. |
B |
| 29 |
Hand dynamometer/pinchmeter, mechanical |
Mechanical device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. |
A |
| 30 |
Hydrotherapy treadmill |
Powered device intended for use partially immersed in water, e.g., in a hydrotherapy tank, to provide additional resistance to treadmill walking exercise without increasing the impact and/or stress on the patient's joints. |
A |
| 31 |
Interferential electrical stimulation system |
Intended to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies that cross-over/interfere, producing a beating frequency at the treatment point. |
C |
| 32 |
Manual goniometer |
Non-powered device intended to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. |
A |
| 33 |
Medium-wave diathermy treatment system |
Intended to produce therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz. |
B |
| 34 |
Microwave diathermy treatment system |
Intended to produce therapeutic heat 1 to 2 cm below the skin within specific volumes of the body through the transcutaneous transmission of high-frequency electromagnetic (EM) energy, typically 2,450 megahertz (MHz) [microwave], to promote tissue healing and pain relief. |
B |
| 35 |
Musculoskeletal infrared phototherapy unit |
Intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. |
B |
| 36 |
Musculoskeletal intense therapeutic ultrasound system |
Intended to produce and deliver intense therapeutic ultrasound (ITU) waves through the skin to create ablative lesions in subcutaneous soft tissues (e.g., muscles, tendons). |
C |
| 37 |
Musculoskeletal/physical therapy laser |
Intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, disorders of the joints and soft/connective tissues), improving blood circulation in the treated areas to facilitate healing, or for nonneedle acupuncture. |
C |
| 38 |
Parallel bar exerciser |
Intended to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. |
A |
| 39 |
Physical therapy massager |
Electrically powered device intended to provide therapeutic massage to a larger area than hand-held massaging devices. |
B |
| 40 |
Physical therapy paraffin wax bath |
Intended to be filled with liquid paraffin wax for physical therapy. |
B |
| 41 |
Physical therapy steam bath |
Intended to apply hot steam as a physical therapy to a patient. |
B |
| 42 |
Pulsed signal therapy system |
Intended to regenerate damaged cartilage, particularly by stimulating the production of collagen types that are present in healthy cartilage. |
C |
| 43 |
Short-wave diathermy treatment system |
Intended to provide therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz. |
C |
| 44 |
Standard treadmill, mechanical |
Intended to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness. |
A |
| 45 |
Standard treadmill, powered |
Electrically powered unit intended to facilitate in-place walking, jogging, or running to promote muscle redevelopment, restore motion to joints, and promote weight loss and cardiovascular fitness. |
A |
| 46 |
Telemetric diagnostic spirometer |
Battery-powered portable device intended to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function (e.g., vital capacity, peak expiratory flow, forced expiratory volume, forced expiratory flow), and transmit the pulmonary function data via a communication device to a healthcare professional(s) at a remote server. |
B |
| 47 |
Therapeutic nuclear magnetic resonance system |
Intended to influence cellular metabolism using nuclear magnetic resonance (NMR) for the treatment of degenerate and pathological changes to the movement/support profiles of a patient's body, particularly diseased skeletal joints, bones, and surrounding muscle tissue (e.g., cervical and lumbar spine, shoulders, elbows, hands, hips, knees, feet). |
C |
| 48 |
Wall bars |
Device permanently fixed to the wall intended for training and rehabilitation to regain and/or improve body movement and balance and/or for strengthening the limbs and trunk of the body. |
A |
| CATEGORY: physical support |
|
|
|
| S.NO. |
Name of Medical Device |
Intended Use |
Classification India as per First Schedule part- 1 MDR 2017 |
| 1 |
Ankle continuous passive motion exerciser |
Electrical device intended to continuously move the ankle joint (e.g., flexion, inversion/eversion) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint. |
B |
| 2 |
Ankle/foot orthosis |
Intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. |
A |
| 3 |
Balance board |
Intended to train patients with difficulties in balance (e.g., paraplegics or stroke victims) for balance training. |
A |
| 4 |
Bed traction frame |
Intended to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip). |
A |
| 5 |
Body arch traction table |
Intended to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch. |
A |
| 6 |
Canalith repositioning procedure chair, manual |
Intended to treat balance disorders (e.g., benign paroxysmal positional vertigo, canalithiasis) caused by displaced canaliths (otoconia) in the inner ear of the patient. |
A |
| 7 |
Cervical spine collar |
Intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). |
A |
| 8 |
Cervical spine immobilization head ring |
Intended to be fixed to the skull of a patient at brow level using pointed, steel, threaded bolts (typically four) that are adjusted to penetrate the outer bone of the skull. |
NA |
| 9 |
Cervicothoracic spine orthosis |
Intended to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine. |
A |
| 10 |
Cervicothoracolumbosacral spine orthosis |
Intended to encompass the cervicothoracolumbosacral spine region of the neck and trunk. |
A |
| 11 |
Chest oscillation airway secretion clearing system |
Intended to rapidly inflate and deflate against the chest wall of the patient for promoting airway clearance by creating high frequency chest wall oscillation (HFCWO), resulting in the mobilization of bronchial secretions. |
B |
| 12 |
Collar and cuff arm sling material |
Fabric and form composite material intended to immobilize forearm, elbow, humerus, or shoulder injuries. |
A |
| 13 |
Cranial orthosis |
Intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. |
A |
| 14 |
Elbow orthosis |
Intended to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. |
A |
| 15 |
Finger orthosis |
Intended to encompass the whole or part of the finger to support, align, prevent, or correct deformities/injuries or to improve function of the finger. |
A |
| 16 |
Flotation therapy bed, adult |
Intended to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. |
B |
| 17 |
Flotation therapy bed, neonatal |
Intended to minimize pressure points on neonatal patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. |
B |
| 18 |
Foot orthosis |
Intended to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet. |
A |
| 19 |
Hand orthosis |
Intended to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve function of the hand. |
A |
| 20 |
Hand/finger splint |
Intended to immobilize an injured hand to protect injuries to, e.g., the digits, metacarpals, and wrist during the healing process. |
A |
| 21 |
Hand/wrist continuous passive motion exerciser |
Intended to continuously move the metacarpal/interphalangeal joints (e.g., flexion and extension) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joints. |
B |
| 22 |
Hip/knee continuous passive motion exerciser |
Intended to provide continuous passive motion (CPM) exercise therapy for the hip and/or knee, typically following joint surgery/trauma to promote healing; some types may also operate with patient assistance under controlled active motion (CAM). |
B |
| 23 |
Horizontal non-powered traction system |
Non-powered device intended to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae by means of attached harnesses whilst the patient typically lies in a supine position on the table during treatment. |
A |
| 24 |
Incentive spirometer |
Intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. |
A |
| 25 |
Intermittent traction system |
It is an AC powered electronic device. Intended to apply and relieve pre-set traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. |
B |
| 27 |
Knee immobilizer |
Intended to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. |
A |
| 28 |
Neurocontrolled ambulation exoskeleton |
Intended to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by transmission of the patient’s residual nerve function, via cutaneous electrodes, to the device motor assembly. |
C |
| 29 |
Orthopaedic bed |
Intended to provide support for skeletal traction to stabilize fracture sites. |
A |
| 30 |
Paediatric dorsiflexion slant board |
Intended to be used in the treatment of various medical conditions (e.g., congenital, neurological, post-traumatic) in paediatrics, where tendon tightness and muscle contracture affect the ability to dorsiflex the foot, possibly leading to an abnormal gait. |
A |
| 31 |
Parapodium walking frame |
Intended to encompass and provide support for the body of a patient who is unable to stand unassisted to help them move (walk) by changing their centre of gravity (COG). |
A |
| 33 |
Shoulder continuous passive motion exerciser |
Intended to continuously move the shoulder joint (e.g., flexion, rotation, adduction/abduction) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint. |
B |
| 34 |
Shoulder immobilizer |
Intended to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound. |
A |
| 35 |
Swivel-walker |
Intended to encompass and provide support for the body of a patient who is unable to stand unassisted, to help them move (walk) by rocking sideways (shifting their weight from side-to-side with a shoulder movement) which makes the footplate of the device swivel so that it “walks” forward. |
A |
| 36 |
Toe separator |
Intended to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. |
A |
| 38 |
Wrist immobilizer |
Intended to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. |
A |
| CATEGORY: INTERVENTIONAL RADIOLOGY |
|
|
|
| S.NO. |
Name of Medical Device |
Intended Use |
Classification India as per First Schedule part- 1 MDR 2017 |
| 1 |
Scintillation (gamma) camera |
Intended to image the distribution of radionuclides in the body by means of a photon radiation detector. |
A |
| 2 |
Positron camera |
Intended to image the distribution of positron-emitting radionuclides in the body. |
A |
| 3 |
Nuclear whole body counter |
Intended to measure the amount of radionuclides in the entire body. |
A |
| 4 |
Bone densitometer |
Intended to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. |
C |
| 5 |
Bone sonometer |
Transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. |
B |
| 6 |
Emission computed tomography system |
Intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. |
C |
| 7 |
Fluorescent scanner |
Measures the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. |
C |
| 8 |
Nuclear rectilinear scanner |
Intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. |
A |
| 9 |
Nuclear tomography system |
Detects nuclear radiation in the body and produces images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. |
C |
| 10 |
Nuclear uptake probe |
Measures the amount of radionuclide taken up by a particular organ or body region. |
A |
| 11 |
Nuclear whole body scanner |
Measures and images the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction with respect to the patient. |
A |
| 12 |
Nuclear scanning bed |
Adjustable bed intended to support a patient during a nuclear medicine procedure. |
A |
| 13 |
Radionuclide dose calibrator |
Intended to assay radionuclides before their administration to patients. |
B |
| 14 |
Nuclear anthropomorphic phantom |
Human tissue facsimile containing a radioactive source or cavity intended to calibrate nuclear uptake probes or other medical instruments. |
A |
| 15 |
Nuclear flood source phantom |
Device filled with a uniformly distributed solution of a desired radionuclide intended to calibrate a medical gamma camera-collimator system for uniformity of response. |
A |
| 16 |
Radionuclide rebreathing system |
Intended for nuclear medicine ventilatory tests by containing a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permitting it to be respired by the patient. |
C |
| 17 |
Nuclear sealed calibration source |
Consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors. |
A |
| 18 |
Nuclear electrocardiograph synchronizer |
Intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images. |
A |
| 19 |
Radionuclide test pattern phantom |
Consists of an arrangement of radiopaque or radioactive material sealed in a solid pattern intended to serve as a test for a performance characteristic of a nuclear medicine imaging device. |
A |
| 20 |
Nonfetal ultrasonic monitor |
Projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave, intended for investigation of nonfetal blood flow and other nonfetal body tissues in motion. |
B |
| 21 |
Ultrasonic pulsed doppler imaging system |
Combines continuous wave doppler-effect technology with pulsed-echo effect technology to determine stationary body tissue characteristics or dynamic tissue characteristics such as velocity of blood or tissue motion. |
B |
| 22 |
Ultrasonic pulsed echo imaging system |
Intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. |
B |
| 23 |
Diagnostic ultrasonic transducer |
Made of a piezoelectric material that converts electrical signals into acoustic signals and vice versa, intended for use in diagnostic ultrasonic medical devices. |
B |
| 24 |
Angiographic x-ray system |
Intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. |
C |
| 25 |
Diagnostic x-ray beam-limiting device |
Intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam. |
C |
| 26 |
Cine or spot fluorographic x-ray camera |
Intended to photograph diagnostic images produced by x-rays with an image intensifier. |
C |
| 27 |
Electrostatic x-ray imaging system |
Uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. |
C |
| 28 |
Radiographic film marking system |
Intended to add identification and other information onto radiographic film by means of exposure to visible light. |
A |
| 29 |
Image-intensified fluoroscopic x-ray system |
Intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. |
C |
| 30 |
Non-image-intensified fluoroscopic x-ray system |
Intended to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. |
C |
| 31 |
Spot-film device |
An electromechanical component of a fluoroscopic x-ray system used to position a radiographic film cassette to obtain radiographs during fluoroscopy. |
C |
| 32 |
Diagnostic x-ray high voltage generator |
Intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. |
B |
| 33 |
Mammographic x-ray system |
Intended to produce radiographs of the breast. |
C |
| 34 |
Full-field digital mammography system |
Intended to produce planar digital x-ray images of the entire breast. |
C |
| 35 |
Photofluorographic x-ray system |
Includes a fluoroscopic x-ray unit and a camera used to produce and photograph a fluoroscopic image of the body. |
C |
| 36 |
Diagnostic x-ray tube housing assembly |
An x-ray generating tube encased in a radiation-shielded housing for diagnostic purposes. |
A |
| 37 |
Diagnostic x-ray tube mount |
Intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. |
A |
| 38 |
Pneumoencephalographic chair |
Intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain). |
B |
| 39 |
Radiologic patient cradle |
A support device used for rotational positioning about the longitudinal axis of a patient during radiologic procedures. |
A |
| 40 |
Radiographic film |
A thin sheet of radiotransparent material coated with photographic emulsion intended to record images during diagnostic radiologic procedures. |
A |
| 41 |
Radiographic film cassette |
Intended to hold a radiographic film in close contact with an x-ray intensifying screen and provide a light-proof enclosure for direct exposure of radiographic film. |
B |
| 42 |
Radiographic film/cassette changer |
Intended to move a radiographic film or cassette between x-ray exposures and to position it during the exposure. |
B |
| 43 |
Radiographic film/cassette changer programmer |
Intended to control the operations of a film or cassette changer during serial medical radiography. |
C |
| 44 |
Wall-mounted radiographic cassette holder |
A support intended to hold and position radiographic cassettes for a radiographic exposure. |
A |
| 45 |
Radiographic film illuminator |
Contains a visible light source covered with a translucent front and is used to view medical radiographs. |
A |
| 46 |
Automatic radiographic film processor |
Intended to develop, fix, wash, and dry film automatically and continuously for medical purposes. |
C |
| 47 |
Radiographic grid |
Consists of alternating radiolucent and radiopaque strips placed between the patient and the image receptor to reduce scattered radiation reaching the image receptor. |
A |
| 48 |
Radiographic head holder |
Intended to position the patient's head during a radiographic procedure. |
A |
| 49 |
Radiologic quality assurance instrument |
Measures a physical characteristic associated with another radiologic device for quality assurance purposes. |
A |
| 50 |
Radiographic anthropomorphic phantom |
Simulates a human body for positioning radiographic equipment. |
A |
| 51 |
Radiographic intensifying screen |
Thin radiolucent sheet coated with luminescent material that transforms x-ray photons into visible light to expose radiographic film. |
A |
| 52 |
Radiographic ECG/respirator synchronizer |
Coordinates an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle. |
A |
| 53 |
Radiologic table |
Supports a patient during radiologic procedures, may be fixed or tilting, and may be electrically powered. |
C |
| 54 |
Transilluminator for breast evaluation |
Electrically powered device using low-intensity emissions of visible light and near-infrared radiation to visualize translucent breast tissue for diagnosis. |
D |
| 55 |
Medical image storage device |
Provides electronic storage and retrieval functions for medical images, employing magnetic and optical discs, magnetic tape, and digital memory. |
A |
| 56 |
Radiological computer-assisted diagnostic software for lesions suspicious of cancer |
Image processing software intended to aid in the characterization of lesions suspicious for cancer based on features extracted from medical images. |
C |
| 57 |
Medical image analyzer |
Identifies, marks, or directs attention to portions of radiology images that may reveal abnormalities, incorporating pattern recognition and data analysis capabilities. Not intended to replace review by a qualified radiologist or for triage or diagnosis recommendation. |
C |
| 58 |
Radiological computer aided triage and notification software |
Aids in prioritization and triage of radiological medical images, notifying clinicians of time-sensitive images for review based on computer-aided analysis. |
C |
| 59 |
Full-body MRI system, permanent magnet |
General-purpose MRI system designed for scanning any targeted area of the body, featuring a permanent magnet assembly. |
C |
| 60 |
Full-body MRI system, resistive magnet |
General-purpose MRI system designed for scanning any targeted area of the body, featuring a resistive magnet assembly. |
C |
| 61 |
Full-body MRI system, superconducting magnet |
General-purpose MRI system designed for scanning any targeted area of the body, featuring a superconducting magnet assembly. |
C |
| 62 |
Foetal cardiac monitor |
AC-powered device to detect, measure, and display foetal heart activity during the perinatal period. |
D |
| 63 |
Foetal Doppler system |
Portable, hand-held, battery-powered device to noninvasively detect foetal heart beats using ultrasound/Doppler technology, aiding in determining foetal viability. |
C |
| 64 |
Flexible ultrasound colonoscope |
Endoscope with a flexible inserted portion for visual examination and treatment of the entire colon during colonoscopy. |
B |
| 65 |
Flexible ultrasound duodenoscope |
Endoscope with a flexible inserted portion and ultrasound probe for visual examination and treatment of the duodenum during duodenoscopy. |
B |
| 66 |
Flexible ultrasound gastroduodenoscope |
Endoscope with a flexible inserted portion and ultrasound probe for visual examination and treatment of the upper gastrointestinal tract, including the oesophagus, stomach, and duodenum, during gastroduodenoscopy. |
B |
| 67 |
Flexible ultrasound laparoscope |
Endoscope with a flexible inserted portion and ultrasound probe for visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs during laparoscopy. |
B |
| 68 |
Flexible ultrasound bronchoscope |
Endoscope with a flexible inserted portion for visual examination and treatment of the trachea, bronchi, and lungs during bronchoscopy, inserted through the mouth or nose. |
B |
| 69 |
Bladder ultrasound imaging transducer |
Ultrasound imaging transducer assembly designed to be positioned within the bladder to steer, focus, and detect ultrasound beam and echoes, manually or under endoscopic guidance. |
B |
| 70 |
Blood flowmeter catheter, Doppler |
Flexible tube inserted into a blood vessel to determine blood-flow velocity using the Doppler principle by measuring ultrasonic frequency shift between transmitted and reflected signals. |
C |
| 71 |
General-purpose ultrasound imaging system |
Stationary or mobile assembly of devices to collect, display, and analyze ultrasound images during various extracorporeal and/or intracorporeal ultrasound imaging procedures. |
B |
| CATEGORY: Rheumatology |
|
|
|
| S.NO. |
Name of Medical Device |
Intended Use |
INDIA |
| 1 |
Back brace |
Provides strong support to the lower back and waist. Stabilizes and supports shoulders, chest, and back, aiding in posture correction. |
1 |
| 2 |
Canes |
Assist seniors and elderly individuals with various types of arthritis, including patellofemoral or other knee, hip, and hand arthritis. |
1 |
| 3 |
Lateral wedge insoles |
Intended for the treatment of pain in patients with medical knee osteoarthritis. |
1 |
| 4 |
Grab bars in showers and tubs |
Horizontal bars on walls aid in getting in and out of the tub, while vertical bars provide support and assistance in accessing water controls. |
1 |
| 5 |
Shoe insert |
Medical insole placed inside a shoe to relieve symptoms of athlete's foot infection by absorbing moisture. |
1 |
| 6 |
Reachers |
Assist arthritis sufferers in picking up or extending their reach to retrieve items otherwise difficult to access. |
1 |
| 7 |
Orthopaedic pillow |
Designed to correct body positioning in bed or while lying on any other surface. |
1 |
| 8 |
Orthopaedic shoes |
Protect toes, feet, and ankles from injuries such as crushing of toes, twisting of ankles, and torn muscles in the legs. |
1 |
| 9 |
Stairway chair lift |
Intended to assist individuals in ascending staircases with ease, especially those with mobility issues. |
1 |
| 10 |
Toilet frames |
Aid individuals with rheumatoid, osteoarthritis, or elderly arthritis in minimizing difficulty while using the toilet. |
1 |
| 11 |
Bottle and jar openers |
Assist individuals with arthritic hands or fingers in opening jars and bottles, which can be difficult and painful. |
1 |
| CATEGORY: DERMATOLOGICAL &PLASTIC SURGERY |
|
|
|
| S.NO. |
Device name |
Intended Use |
Current CDSO Classification |
| 1 |
Organ bag |
A flexible plastic bag used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss. |
B |
| 2 |
Polymer Ligating Clips |
Intended for use in procedures involving ligation of vessels or tissue structures. Contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies. |
C |
| 3 |
Surgical camera and accessories |
Used to record operative procedures. |
A |
| 4 |
Implantable ligating clip |
A clip-like device intended to connect internal tissues to aid healing. Not absorbable. |
C |
| 5 |
Laser surgical instrument for use in general and plastic surgery and in dermatology |
A carbon dioxide laser intended to cut, destroy, or remove tissue by emitting light energy. |
C |
| 6 |
Low energy ultrasound wound cleaner |
A device that uses ultrasound energy to vaporize a solution and generate a mist for cleaning and maintenance debridement of wounds. |
B |
| 7 |
Non-powdered surgeon's glove |
Intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. |
A |
| 8 |
Surgical drape and drape accessories |
Made of natural or synthetic materials, intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. |
B |
| 9 |
Suture retention device |
Intended to aid wound healing by distributing suture tension over a larger area in the patient. |
B |
| 10 |
Ultraviolet lamp for dermatologic disorders |
Intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. |
C |
| 11 |
Wound autofluorescence imaging device |
A tool to view autofluorescence images from skin wounds that are exposed to an excitation light. Not intended to provide quantitative or diagnostic information. |
B |
| 12 |
Battery-powered trephine system |
A rotary surgical device consisting of a motor and a cylindrical or trephine insertion portion. Used for removal of the intervertebral disc, other hard tissues, or soft tissues. This is a battery-driven device. |
B |
| 13 |
Carbon dioxide laser |
Used in surgical procedures, utilizing carbon dioxide as the substrate. Widely used in several clinical fields such as gynecology, neuroscience, and dermatology. |
C |
| 14 |
Colonoscope, General & Plastic Surgery |
Used for the removal of foreign bodies, excision of tumors or colorectal polyps (polypectomy), and control of hemorrhage. Important in diagnosing intestinal cancer. |
B |
| 15 |
Copper vapour laser |
Used in surgical procedures, utilizing copper vapor as the substrate. Used in dermatology for treatment of cutaneous vascular lesions (e.g., port-wine stains, telangiectasia). |
C |
| 16 |
Cryosurgical unit and accessories |
Intended to destroy tissue during surgical procedures by applying extreme cold, consisting of a liquid nitrogen cooled cryoprobe and accessories. |
B |
| 17 |
Dermal dilator |
A device temporarily implanted subcutaneously to dilate the surrounding skin, usually by infusing solutions such as saline solution. |
B |
| 18 |
Dermatome |
A surgical knife used to harvest the skin for grafting, either manual or electric-powered. |
A |
| 19 |
Dermatome skin approximation tape |
Tape with adhesive on both sides, attached onto a skin graft knife to collect a skin graft tissue. Single-use device. |
A |
| 20 |
Drape adhesive |
Device intended to be placed on the skin to attach a surgical drape. |
A |
| 21 |
Electrically-powered trephine system |
A rotary surgical device used for removal of the intervertebral disc or other hard and soft tissues, consisting of a motor and a cylindrical or trephine insertion portion. |
B |
| 22 |
Electrosurgical cutting and coagulation device and accessories |
Device intended to remove tissue and control bleeding by use of high-frequency electrical current. |
C |
| 23 |
Electrosurgical device for over-the-counter aesthetic use |
Device using radiofrequency energy for non-invasive aesthetic use, producing localized heating within tissues. |
B |
| 24 |
Esophagoscope, General & Plastic Surgery |
Endoscope used for visual examination, diagnosis, and treatment of the esophagus, inserted through the oral cavity. |
B |
| 25 |
Eye pad |
Pad made of various materials, intended for use as a bandage over the eye for protection or absorption of secretions. |
A |
| 26 |
Gas-powered dermatome |
Surgical device operated by gas pressure, used to cut a thin piece of skin for grafting or to resect a small skin lesion. |
B |
| 27 |
Gas-powered surgical saw |
Saw with a handpiece generating vibration or reciprocal movements, using compressed air or compressed nitrogen. |
B |
| 28 |
Gas-powered trephine system |
A rotary surgical device operated by gas pressure, used for removal of the intervertebral disc, other hard tissues, or soft tissues. |
B |
| 29 |
Gastroscope, General & Plastic Surgery |
A flexible tube with a small light and video camera attached to the end, used for visual examination and tissue sampling. |
C |
| 30 |
General electrosurgical unit |
A device with accessories that cuts/coagulates tissues with high-frequency current or electricity/heat, used by physicians for incision or coagulation. |
C |
| 31 |
Hemostatic knife |
A surgical severing instrument with a blade heated by an electric current for achieving hemostasis directly on body tissues. |
B |
| 32 |
Hydrophilic wound dressing |
A sterile or non-sterile device intended to cover and absorb exudate from a wound, made of nonresorbable materials with hydrophilic properties. |
A |
| 33 |
Implantable staple |
A staple-like device intended to connect internal tissues to aid healing, non-absorbable. |
C |
| 34 |
Internal tissue marker |
A device used to demarcate selected sites on internal tissues prior to or during general surgical procedures. |
A |
| 35 |
Irrigating wound retractor device |
A device used by surgeons to retract, protect, irrigate surgical wounds, and remove fluid from the wound. |
B |
| 36 |
Laparoscope, General & Plastic Surgery |
Electrodes intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. |
C |
| 37 |
Laparoscopy Tray |
A tray intended for single-use to enable a suitable trained healthcare professional to perform a laparoscopic procedure. |
A |
| 38 |
Liposuction catheter |
A rigid tube inserted transdermally into the subcutaneous layer for removal of fatty deposits, for single-use. |
B |
| 39 |
Manual operating table and accessories and manual operating chair and accessories |
Non-powered devices with movable components, intended to support a patient during diagnostic examinations or surgical procedures. |
A |
| 40 |
Manually-operated dermatome |
A hand-held surgical device used to sever a thin piece of skin for grafting or to resect a small skin lesion, requiring a dedicated blade. |
A |
| 41 |
Occlusive wound dressing |
A nonresorbable device intended to cover a wound, provide or support a moist wound environment, and allow the exchange of gases. |
A |
| 42 |
Plastic surgery osteotome |
A surgical instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery, hand-held by the surgeon and used with a surgical mallet or hammer. |
A |
| 43 |
Powered corneal trephine |
An electric cylindrical device equipped with a blade for resection/removal of a ring-shaped piece of corneal tissue (corneal button) in ophthalmic surgery. |
B |
| 44 |
Powered dermatome |
An electric surgical device used for removal of a fragment of damaged skin or thinly slicing the skin of a donor for skin graft, requiring a dedicated blade. |
B |
| 45 |
Powered suction pump |
A portable device powered by AC or compressed air, used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. |
B |
| 46 |
Removable skin clip |
A clip-like device intended to temporarily connect skin tissues to aid healing, not absorbable. |
B |
| 47 |
Removable skin staple |
A staple-like device intended to temporarily connect external tissues to aid healing, not absorbable. |
B |
| 48 |
Reusable dermatome blade |
A blade attached to a skin graft knife for harvesting skin grafts, reusable after sterilization. |
A |
| 49 |
Single-use dermatome blade |
A blade attached to a dermatome for collecting skin grafts, intended for single-use. |
B |
| 50 |
Skin marker |
A pen-like device used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement. |
A |
| 51 |
Skin Stapler |
Intended to close lacerations on the outer layer of the dermis. |
B |
| 52 |
Soft tissue trephine |
A cylindrical or coronary saw used to resect discs of soft tissues other than bones. |
B |
| 53 |
Surgical apparel |
Devices intended to be worn by operating room personnel during surgical procedures to protect against transfer of microorganisms, body fluids, and particulate. |
A |
| 54 |
Surgical guillotine |
A cutter consisting of a metal frame and a sliding cutter used to sever tissues, available in various configurations and sizes. |
A |
| 55 |
Surgical lamp |
A device used to provide visible illumination of the surgical field or the patient. |
A |
| 56 |
Surgical microscope and accessories |
An AC-powered device used during surgery to provide a magnified view of the surgical field. |
A |
| CATEGORY: PEDIATRICS AND NEONATOLOGY |
|
|
|
| S.NO. |
Name of Product |
Intended Use |
Classification Indiaas per First Schedule Part 1 MDR 2017 |
| 1 |
Aerosol tent, paediatric |
A flexible enclosure designed to cover the bed of an infant or small child to provide an aerosolized environment of breathing gases/vapours for medication therapy, typically used for the treatment of breathing disorders such as asthma. Reusable. |
B |
| 2 |
Airway Pressure / Oxygen Monitor |
A device designed to continuously measure and display the breathing circuit pressure and oxygen concentration levels of respiratory gases delivered to a patient through positive pressure ventilation systems. Used for neonatal, paediatric, and adult patients. Rechargeable battery included for mobile use. |
B |
| 3 |
Anaesthesia Facemask, single use (paediatric) |
A disposable, form-shaped device placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. Made of nonwoven materials and typically includes a 15 mm connector. Single-use, non-sterile. |
B |
| 4 |
Anaesthesia Facemask, reusable (paediatric) |
A reusable, form-shaped device placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. Made of nonwoven materials and typically includes a 15 mm connector. Reusable. |
B |
| 5 |
Antimicrobial endotracheal tube, paediatric |
A sterile tube inserted into the trachea coated with an antimicrobial agent to prevent infection. Includes a connector, inflatable cuff, radiopaque feature, and built-in pilot balloon. Single-use. |
C |
| 6 |
Assistive ergonomic chair mobility base |
A manually-operated, height-adjustable mobile support for an assistive ergonomic chair used by healthcare providers to provide mobility for disabled (often paediatric) patients. Includes a chair lifting mechanism. Not a wheelchair component. |
A |
| 7 |
Breathing circuit gas-flow sensor, reusable |
A device with a transducer to detect gas movement in a breathing circuit, connected to a ventilator to monitor gas flow to and from the patient. Reusable. |
C |
| 8 |
Breathing circuit gas-flow sensor, single-use |
A sterile device with a transducer to detect gas movement in a breathing circuit, connected to a ventilator to monitor gas flow to and from the patient. Single-use. |
C |
| 9 |
Cerebral oximeter |
A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. It uses a cerebral sensor(s) having a light source and photodiode detector that is/are placed on the scalp/head. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2. |
C |
| 10 |
Circulating-air whole-body heating/cooling system pad, reusable |
An underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). Reusable. |
B |
| 11 |
Circulating-air whole-body heating/cooling system pad, single-use, sterile |
A sterile underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). Single-use. |
B |
| 12 |
Circulating-fluid whole-body heating/cooling system pad, reusable |
An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body heating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). Reusable. |
B |
| 13 |
Circulating-fluid whole-body heating/cooling system pad, single-use |
A non-sterile underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body heating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). Single-use. |
B |
| 14 |
Closed-ended adhesive infant/paediatric urine collection bag |
A sterile, flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/paediatric patient. It is not designed with an opening for urine drainage and is typically used for biochemical, cytological and/or bacteriological sampling. Single-use. |
B |
| 15 |
Craniofacial bone screw, bioabsorbable |
A small, sterile, threaded rod with a slotted head used for craniofacial bone (including the maxilla and/or mandible) fracture fixation by being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). Single-use. |
D |
| 16 |
Craniofacial bone screw, non-bioabsorbable, sterile |
A small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Single-use. |
C |
| 17 |
Cuff-suction endotracheal tube |
A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. Single-use. |
C |
| 18 |
Electric pad whole-body heating system |
An assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. Reusable. |
B |
| 19 |
Electric pad whole-body heating system pad |
An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an electrical heating pad system used to heat a patient’s whole body (i.e., elevate core body temperature) typically in surgical and intensive care settings. Reusable. |
B |
| 20 |
Enteral feeding kit, adult/paediatric, sterile |
A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. Long term use. |
C |
| 21 |
Exhaled-gas oesophageal intubation detector, paediatric |
A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. Single-use. |
A |
| 22 |
External counterpulsation system, paediatric |
A noninvasive, stationary assembly of devices intended to assist the blood circulation of a paediatric patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. Reusable. |
B |
| 23 |
External defibrillator electrode, paediatric, reusable |
An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. Reusable. |
B |
| 24 |
External defibrillator electrode, paediatric, single-use |
An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. Single-use. |
B |
| 25 |
Flexible bone nail, non-sterile |
A non-sterile, bending rod made of metal designed for insertion into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. Single-use. |
C |
| 26 |
Flexible bone nail, sterile |
A sterile, bending rod made of metal designed for insertion into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. Single-use. |
C |
| 27 |
Funnel chest remodelling bar |
A non-sterile implantable device intended to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum. Single-patient device. |
C |
| 28 |
Growth-correction orthopaedic fixation plate kit |
A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients. Single-use device. |
C |
| 29 |
Hepatic ultrasound elastography system applicator |
A non-sterile hand-held device for transcutaneous measurement of liver stiffness based on transient elastography. Reusable. |
B |
| 30 |
Infant apnoea monitor |
A mains electricity (AC-powered) device used to register the respiratory rate of an infant and give an alarm signal when pre-set limits are exceeded due to apnoea. |
C |
| 31 |
Infant bed crib top |
A covering attached to the top of an infant bed to protect the infant from accidental damage. Reusable. |
B |
| 32 |
Infant bed restraint |
A device designed to limit the movement of infants and/or toddlers when lying in its bed or crib. Reusable. |
B |
| 33 |
Infant care table |
A specially made table used for nursing newborn babies. Reusable. |
A |
| 34 |
Infant heat shield |
A protective guard intended to reduce heat loss during the radiant warming of primarily premature infants. Single-use. |
B |
| 35 |
Infant incubator control unit |
An electronic unit used to monitor and regulate the temperature and environmental features of an infant incubator. Reusable. |
C |
| 36 |
Infant incubator warming hood |
A heating element positioned above an incubator's chamber designed to provide warmth for the chamber's environment. Single-use. |
A |
| 37 |
Infant inguinal hernia truss |
A bandage-like strap of worsted yarn intended to be worn over the groin to prevent protrusion of abdominal contents in an infant with an inguinal hernia. Single-use. |
A |
| 38 |
Infant limb immobilizer, reusable |
A non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable. Reusable. |
A |
| 39 |
Infant limb immobilizer, single-use |
A non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable. Single-use. |
A |
| 40 |
Infant resuscitation cabinet |
A small chamber used for the emergency resuscitation of newborn infants who do not breathe spontaneously at birth. Equipped with various resuscitation devices. |
B |
| 41 |
Infant resuscitation table |
A flat surface on which newborn infants who do not breathe spontaneously at birth are placed for emergency resuscitation. Equipped with various resuscitation devices. |
B |
| 42 |
Infant scale, electronic |
An electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes. |
A |
| 43 |
Infant sleep positioner |
A non-rigid device intended to modify the sleeping position/posture of infants to prevent deformational plagiocephaly. Reusable. |
A |
| 44 |
Infant warmer |
A mobile device containing an infrared heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. |
C |
| 45 |
Infant whole-body immobilizer, reusable |
A device intended to temporarily render an infant's whole body immovable while undergoing therapeutic or diagnostic interventions. Reusable. |
A |
| 46 |
Infant whole-body immobilizer, single-use |
A non-sterile device intended to temporarily render an infant's whole body immovable while undergoing therapeutic or diagnostic interventions. Single-use. |
A |
| 47 |
Infant/regional-body warmer |
A device containing an infrared heating element(s) designed to emit controlled, evenly distributed heat to a newborn/infant patient or to provide heat to the limbs of a more mature person. Stationary device. |
C |
| 48 |
Infant-hammock bed mattress |
A foam-filled case with a central meshed/netted depression designed to cradle a young infant during sleep/rest. Reusable. |
A |
| 49 |
Infant-hammock bed mattress overlay |
A portable pad with a central meshed/netted depression designed to cradle a young infant during sleep/rest. Reusable. |
A |
| 50 |
Internal defibrillator electrode, paediatric |
An electrical conductor used to transmit a controlled electrical shock directly to the exposed heart muscle of a pre-pubescent patient during cardiopulmonary surgery. Reusable. |
C |
| 51 |
Lacrimal intubation set |
A collection of sterile devices designed to prevent/treat obstruction of and drain tears from the lacrimal ducts. |
C |
| 52 |
Liquid crystal vein locator |
A device designed to measure skin temperature to assist healthcare professionals in locating peripheral veins before venipuncture. |
B |
| 53 |
Microlaryngeal probe |
A surgical instrument designed for paediatric laryngology and phonatory microsurgery applications. Reusable. |
A |
| 54 |
Multifunction cardiac electrode, paediatric |
An electrical conductor applied to a paediatric patient for defibrillation, pacing, cardioversion, and electrocardiographic monitoring. Single-use. |
C |
| 55 |
Neonatal chest percussor |
A hand-held battery-powered device intended to provide external vibrations to the chest wall of a neonate to help loosen bronchial mucus for expectoration through suctioning. B |
B |
| 56 |
Neonatal CPAP unit |
A mains electricity (AC-powered) device intended to assist noninvasive ventilation of a neonatal/infant patient using continuous positive airway pressure (CPAP) during spontaneous respiration. C |
C |
| 57 |
Neonatal electrocardiographic electrode |
A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to produce an electrocardiogram (ECG). Single-use. B |
B |
| 58 |
Neonatal hypothermia cot |
An assembly of non-powered devices intended to induce and sustain mild hypothermia in a neonatal patient to treat hypoxic-ischemic encephalopathy (HIE). Reusable. B |
B |
| 59 |
Neonatal hypothermia cot heat-conduction mattress |
A patient-contact component of a neonatal hypothermia cot assembly intended to allow heat transfer away from the patient. Reusable. B |
B |
| 60 |
Neonatal hypothermia cot heat-retention pad |
A non-powered component of a neonatal hypothermia cot assembly intended to induce and sustain mild hypothermia in a neonatal patient. Reusable. B |
B |
| 61 |
Neonatal intensive-care ventilator |
A mains electricity (AC-powered) device intended for short-term and long-term ventilatory support for a neonatal/paediatric patient in a critical care setting. C |
C |
| 62 |
Neonatal kangaroo care garment |
A non-sterile, upper body garment intended to allow skin-to-skin contact between parent and infant (kangaroo care). Reusable. A |
A |
| 63 |
Neonatal physiologic monitoring system |
A device assembly designed to continuously measure and display multiple vital physiological parameters of newborn and premature infants. C |
C |
| 64 |
Neonatal pulmonary surfactant catheter |
A sterile, flexible, single-lumen tube intended for the administration of exogenous surfactant to neonates. Single-use. B |
B |
| 65 |
Neonatal/paediatric heart rate monitoring application software |
An application software program intended for heart rate monitoring in neonatal or paediatric ICU settings. C |
C |
| 66 |
Neonatal/paediatric heart rate monitoring hardware |
A device designed to acquire and analyze electrocardiogram (ECG) data from neonatal or paediatric patients. C |
C |
| 67 |
Nitric oxide delivery unit, system-based |
A device for the delivery of precise amounts of nitric oxide to treat severe respiratory disorders. C |
C |
| 68 |
Non-rechargeable public semi-automated external defibrillator electrode, paediatric |
An electrical conductor with integral batteries, designed to defibrillate the heart in pre-pubescent patients. Single-use. B |
B |
| 69 |
Open-ended adhesive infant/paediatric urine collection bag |
A sterile plastic pouch with an adhesive flange for collecting urine from infants. Single-use. B |
B |
| 70 |
Open-surgery manual linear cutting stapler, reprocessed |
A previously used single-use device processed for an additional single-use patient application. C |
C |
| 71 |
Open-surgery manual linear cutting stapler, reusable |
A reusable device intended for open surgery to create anastomoses. C |
C |
| 72 |
Open-surgery manual linear cutting stapler, single-use |
A single-use device for open surgery to create anastomoses. C |
C |
| 73 |
Open-surgery manual linear stapler, reusable |
A reusable device for applying surgical staples to internal soft tissues during open surgery. C |
C |
| 74 |
Open-surgery manual linear stapler, single-use |
A single-use device for applying surgical staples to internal soft tissues during open surgery. C |
C |
| 75 |
Ophthalmic tonometer, battery-operated |
A battery-powered instrument for measuring intraocular pressure. B |
B |
| 76 |
Orthopaedic medialization instrument |
A surgical instrument for restoring anatomical and mechanical axes during orthopaedic correction osteotomies. Reusable. B |
B |
| 77 |
Oxygen administration hood, paediatric |
A device providing enriched oxygen environment for infants, connected to O2 source. Reusable. A |
A |
| 78 |
Oxygen administration tent, neonatal/paediatric |
A flexible enclosure for oxygen therapy in neonatal/paediatric patients. Reusable. B |
B |
| 79 |
Paediatric bed |
A bed with safety features designed for children up to 12 years. Not suitable for neonates/infants. B |
B |
| 80 |
Paediatric blood donor set |
A sterile assembly for creating smaller paediatric volume packs from adult donor blood. Single-use. B |
B |
| 81 |
Paediatric cardiopulmonary bypass cannula |
A tube for accessing arterial or venous vasculature during open heart surgery in paediatric patients. Single-use. C |
C |
| 82 |
Paediatric dental chair, electric |
An electric chair to facilitate dental procedures for paediatric patients. B |
B |
| 83 |
Paediatric dental chair, mechanical |
A manually- or hydraulically-powered chair for paediatric dental procedures. Adjustable and includes head/armrests. B |
B |
| 84 |
Paediatric Dorsiflexion Slant Board |
A standing platform designed to stretch ankle muscles/tendons in children with conditions affecting foot dorsiflexion. Typically made of synthetic polymer materials. Reusable. |
Class A |
| 85 |
Paediatric Strabismus Screening Scanner |
An electrically-powered optic device for screening strabismus and amblyopia risk in children. Utilizes polarized laser light reflections from both eyes. Provides recommendations for referral to an ophthalmologist if abnormalities are detected. |
Class B |
| 86 |
Paediatric Urine Collection/Analysis Kit |
A collection of devices for collecting and analyzing paediatric urine specimens for clinical chemistry analytes. Includes specimen collection undergarment and test strips. Single-use. |
Class A |
| 87 |
Paediatric-Temperature Nasogastric/Orogastric Tube |
A sterile tube with an integrated temperature sensor for enteral feeding or medication delivery in paediatric patients. Captures oesophageal temperature via a thermistor sensor. Single-use. |
Class B |
| 88 |
Polyglyconate Suture |
A synthetic, bioabsorbable suture made from polyglyconate. Intended for wound closure in soft tissue surgeries. Single-use with attached needle. |
Class D |
| 89 |
Blanket/Pad Infant Phototherapy Unit |
A device emitting blue light to treat neonatal jaundice. Consists of a fibreoptic-light source connected to a transparent wrap or pad covering the neonate's body. Suitable for home-use. |
Class B |
| 90 |
Flotation Therapy Bed, Neonatal |
A fixed bed with cushions containing air, water, gel, or other materials for continuous care of newborns. Provides appropriate environmental conditions and may include attachments for a baby warmer. Mounted on wheels. |
Class B |
| 91 |
Mobile Steam Washer/Disinfector |
A mobile unit for cleaning and disinfecting medical devices using steam. Includes a boiler unit, hosing, and hand-held steam application device with accessories. |
Class C |
| 92 |
Otoacoustic Emission System, Battery-Powered |
An assembly of battery-powered devices for recording and analyzing otoacoustic emissions (OAE) to test for hearing deficiencies. Typically includes a portable unit, OAE probe, and eartips. |
Class B |
| 93 |
Otoacoustic Emission System, Line-Powered |
An assembly of mains electricity devices for recording and analyzing otoacoustic emissions (OAE) to test for hearing deficiencies. Typically includes a programmable unit, OAE probe, and eartips. |
Class B |
| 94 |
Overhead Infant Phototherapy Unit |
A device emitting blue light to treat neonatal jaundice. Consists of overhead lamp and Plexiglas shield to filter out ultraviolet radiation. Typically includes a built-in timer. |
Class B |
| 95 |
Phototherapy Eye Protector, Reusable |
A reusable device worn to protect the eyes during light therapy treatment. Designed as goggles, spectacles, or mask-like shield to block harmful rays. |
Class A |
| 96 |
Phototherapy Eye Protector, Single-Use |
A single-use device worn to protect the eyes during light therapy treatment. Typically made of soft materials and affixed to the head using bands or adhesive fasteners. |
Class A |
| 97 |
Respiratory Gas Heating Wire, Infant |
A device integrated within a ventilator breathing circuit to maintain the temperature of inspiratory gases during ventilation of an infant. Consists of a compact heating unit and a length of heated wire. |
Class C |
| 98 |
Stationary Pneumatic High-Frequency Ventilator Respiration Monitor |
A device intended to continuously measure and display respiratory variables associated with the operation of a stationary pneumatic high-frequency ventilator. Typically includes alarms and connectors for attachment to the ventilator. |
Class C |
| 99 |
Syringe Pump |
A device designed to precisely administer a solution with high volume accuracy and rate consistency, especially suitable for neonatal, infant, and critical care applications. Typically includes internal batteries for short-term operation without line power. |
Class C |
| 100 |
Thoracic Electrical Impedance Segmentography System |
An assembly for thoracic bio-impedance measurements to continuously record lung distribution in neonatal/infant patients. Includes a central unit, display, and patient electrodes. |
Class B |
| 101 |
Thoracic Electrical Impedance Segmentography System Electrode Array |
A component of a thoracic electrical impedance segmentography system attached to the skin surface of neonatal/infant patients to transmit electrical signals for lung distribution recording. This is a single-use device. |
Class B |
| 102 |
Transcutaneous Intracranial Pressure Sensor |
An electronic device for noninvasive measurement of intracranial pressure in neonatal patients. Consists of a sensor applied to the fontanel and a cable connected to a monitor for readings. |
Class C |
| 103 |
Wearable Neonatal Heart Rate Meter |
A device to detect and display the heart rate of a neonate, typically within the first few hours after delivery. Consists of a display screen with sensor arms placed around the torso of the newborn. |
Class B |
| 104 |
Antimicrobial Infant Garment |
A piece of clothing intended to be worn by an infant with an infectious or infection-susceptible skin condition to reduce microbial proliferation. Constructed of material preventing/control microbial growth. |
Class B |
| 105 |
Birthing Bath |
A large bath filled with heated water for use before and/or during childbirth. May include features such as connectors and diagnostic attachments. |
Class A |
| 106 |
Boiling Water Sterilizer |
A device for total elimination/inactivation of microorganisms from medical/dental devices and products using boiling water as the sterilizing agent. Typically used in remote areas, at home, and/or in emergency situations. |
Class B |
| 107 |
Newborn-Infant Bed |
A bed designed for newborn babies, usually mounted on a wheeled framework (trolley) and padded or lined with appropriate bedding. Additional heating may be provided. |
Class A |
| 108 |
Resuscitator Face Mask, Reusable |
A flexible device to direct air from a resuscitator to the patient's upper airway and lungs. Made of sterilizable materials and available in various sizes. Reusable. |
Class B |
| 109 |
Resuscitator Face Mask, Single-Use |
A flexible device to direct air from a resuscitator to the patient's upper airway and lungs. Made of sterilizable materials and available in various sizes. Single-use. |
Class B |
| 110 |
Warming Infant Bed, Adjustable |
A bed specifically designed for newborn, sick, or premature babies, featuring a heating pad system and electrically adjustable height and tilt. Used in maternity departments. |
Class B |
| 111 |
Warming Infant Bed, Non-Adjustable |
A non-adjustable bed specifically designed for newborn, sick, or premature babies, featuring a heating pad system. Used in maternity departments. |
Class B |
| 112 |
Bedrail Pad |
A cushion designed to protect patients, especially infants and young children, from contact with bedrails to prevent injuries. Reusable. |
Class A |
| 113 |
Blanket/Pad Infant Phototherapy Unit Tester |
A portable device used with a light meter to test blanket/pad infant phototherapy units. Intended for use by healthcare professionals in clinical settings. |
Class B |
| 114 |
Blood Transfusion Set, Exchange |
An intravascular administration set used to remove a diseased infant's blood and replace it with fresh donor blood or plasma. Single-use. |
Class B |
| 115 |
Blue Light Radiometer |
An instrument to measure radiant flux in the spectral range of 400 to 500 nm during bilirubinemia treatment for newborns and infants. |
Class B |
| 116 |
Cardiac Septostomy Catheter, Balloon |
A flexible tube with an inflatable balloon to create or enlarge the atrial septal defect in infants with congenital cardiac malformations. Single-use. |
Class C |
| 117 |
Cardiac Septostomy Catheter, Blade |
A flexible tube with a collapsible blade for blade atrial septostomy procedures in infants with congenital cardiac malformations. Single-use. |
Class C |
| 118 |
Conventional Infant Incubator |
A unit to maintain appropriate temperature and humidity levels for premature infants and newborns. Features include a clear hood, mattress, and temperature/humidity controls. |
Class C |
| 119 |
Cranial Orthosis |
A custom-made helmet-like device worn on the head of infants with abnormal head shapes to improve cranial symmetry. Single-patient, reusable. |
Class B |
| 120 |
Home BPAP Unit |
A portable device for noninvasive ventilation using bi-level positive airway pressure for adult/child patients affected by obstructive sleep apnoea or requiring respiratory assistance at home. |
Class C |
| 121 |
Multi-Purpose Saline Solution |
A sterile salt solution for multiple applications including inhalation therapy, eye/nose/ear washing, and wound cleansing. Single-use. |
Class B |
| 122 |
Nappy Changing Table, Portable |
A raised platform on a foldable frame for changing nappies/diapers. Portable design for patients with disabilities who require regular changing. |
Class A |
| 123 |
Nasal Aspirator, Electric |
A battery-powered suction device to clear excessive mucus from the nasal passages of infants or children. Handheld with a detachable, washable collection cup. Reusable. |
Class A |
| 124 |
Open Infant Incubator |
An AC-powered unit similar to a standard incubator but open, providing instant access to the infant. Equipped with various medical equipment for intensive care. |
Class B |
| 125 |
Oral Medicine Dropper |
A device for dispensing liquid medicine into a patient's mouth in single drops, typically for infants or small children. Reusable. |
Class A |
| 126 |
Oxygen Breath Analyser |
An AC-powered instrument for intermittent measurements of oxygen content in breath or respiratory gas. Used in pulmonary function tests and critical care. |
Class C |
| 127 |
Oxygen Terminal Unit |
A component of a medical gas pipeline system with an oxygen-specific outlet connection. Mounted to medical supply units for connecting devices requiring oxygen. |
Class A |
| 128 |
Pulmonary Function Analysis System, Paediatric |
A computerized instrument to assess lung parameters in young children and infants. Used in diagnostic studies and evaluation of diseases. |
Class B |
| 129 |
Reactive-Gel Heating Pad |
An underlay activated by chemical reaction to produce heat for maintaining body temperature in neonates or infants. Single-use. |
Class B |
| 130 |
Respiratory Apnoea Monitoring System |
An assembly of devices to detect cessation of breathing in infants and adults at risk of respiratory failure. Includes alarms and may monitor physiological parameters. |
Class C |
| 131 |
Rocking Infant Bed, Electric |
An AC-powered bed providing motorized rocking movement for newborns to soothe them. Variable speed and movement control. |
Class B |
| 132 |
Skin Transilluminator, Battery-Powered |
A hand-held device with built-in light source and lens to illuminate skin and soft tissues for examination. Used for examining lesions, veins, and anatomical abnormalities. |
Class C |
| 133 |
Skin Transilluminator, Line-Powered |
A hand-held, AC-powered device with built-in light source and lens for illuminating skin and soft tissues for examination. Used for various medical examinations. |
Class C |
| 134 |
Teething Device, Fluid-Filled |
A circular or cylindrical device filled with fluid to soothe gums during teething. Reusable. |
Class B |
| 135 |
Teething Device, Non-Fluid-Filled |
A circular or cylindrical device without fluid to soothe gums during teething. Reusable. |
Class A |
| 136 |
Transport Infant Incubator |
An electrically-powered unit providing controlled environment for maintaining temperature and humidity for premature infants and newborns. Designed for transport with mains or battery power. |
Class C |
| 137 |
Visual-Reinforcement-Audiometry Reward System |
An assembly of devices used with an audiometer to reward infants/children during audiometry. Includes visual rewards and controls for the healthcare professional. |
Class B |
| CATEGORY: ONCOLOGY |
|
|
|
| S.NO. |
Device name |
Intended Use |
Classification India as per first schedule part 1 MDR 2017 |
| 1 |
FerriScan R2-MRI Analysis System |
The FerriScan R2-MRI Analysis System is intended to measure liver iron concentration to aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox. |
C |
| 2 |
Activated-oxygen generator |
Activated Oxygen (Ozone) Activated oxygen, also known as Ozone (O3), is a safe disinfecting agent that SoClean uses to get rid of CPAP bacteria, mold, or viruses inside your CPAP equipment. |
C |
| 3 |
Alternating electric field antimitotic cancer treatment system generator |
Alternating electric fields therapy is a novel anticancer treatment that disrupts tumor cell mitosis. |
C |
| 4 |
Alternating electric field antimitotic cancer treatment system transducer array |
Alternating electric fields therapy is a novel anticancer treatment that disrupts tumor cell mitosis. |
C |
| 5 |
Bladder instillation buffer solution |
A sterile buffer solution intended to be used exclusively for bladder instillation to help create an optimal environment necessary for the effective treatment of superficial bladder cancer with a chemotherapy agent. |
B |
| 6 |
Brachytherapy needle |
A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). |
C |
| 7 |
Breast 3-D infrared imaging/vascular analysis system |
An assembly of mains electricity (AC-powered) devices intended for three-dimensional (3-D) breast imaging and breast vascular analysis, typically used with mammography screening to perform a breast cancer risk examination. |
C |
| 8 |
Cancer risk assessment interpretive software |
An interpretive software program intended to be used in the assessment of risk for developing cancer (e.g., breast, ovarian, prostate, lung, liver, gastric, pancreatic, colorectal). |
C |
| 9 |
Colonic cytology sampling set |
A collection of non-sterile devices intended to collect exfoliated colonic cells (colonocytes) from the surface of human rectal mucosa for colorectal cancer investigation and/or patient screening. |
B |
| 10 |
Colposcope |
An electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. |
B |
| 11 |
Blepharoplasty scissors |
A hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty). It is not intended for intraocular surgery. |
A |
| 12 |
Cryosurgical set |
A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions. |
C |
| 13 |
Capsular tension ring |
A circular band intended to be used to enhance the mechanical stability of a subluxated crystalline lens capsule in the presence of weak or absent supporting zonules. |
A |
| 14 |
Electro cancer therapy system |
An assembly of devices designed for the treatment of tumors and the destruction of their cancerous cells using low-voltage direct current of small intensity delivered via electrodes placed across the affected body area. |
C |
| 15 |
Electronic clinical breast examination system |
A portable assembly of devices designed to electronically measure, map, document, and store information about breast lesions/masses with regard to shape, size, location, consistency/relative hardness during a clinical breast examination (CBE). |
C |
| 16 |
Endocervical aspirator |
A collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction. |
C |
| 17 |
Alternating electric field antimitotic cancer treatment system |
An assembly of portable devices designed to apply low-intensity, intermediate-frequency (100-300 kHz) alternating electric fields to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumor]. |
D |
| 18 |
Balloon kyphoplasty kit |
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. |
C |
| 19 |
Brachytherapy radionuclide phantom, anthropomorphic |
A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs. |
A |
| 20 |
Accelerator system chair |
A seat, typically with legs, that is a component of a therapeutic accelerator system, and used to support and position a seated patient during radiation therapy treatments involving the use of either a medical linear accelerator or non-linear accelerator. |
C |
| 21 |
Accelerator system operator console |
A device that is a component of a linear or a non-linear accelerator system that functions as the primary control panel typically for a betatron or cyclotron system. Depending on the configuration, it can include hardware and software that allows for image and/or data display, related processing, analysis functions, data archiving, and retrieval. |
C |
| 22 |
Accelerator system quality assurance device |
An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. |
C |
| 23 |
Acupressure wristband |
A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. |
B |
| 24 |
Anorectal brachytherapy system applicator, manual |
A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the rectum and/or anus. |
C |
| 25 |
Anorectal brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the rectum and/or anus. |
C |
| 26 |
Antimicrobial postsurgical brassiere |
A woman's undergarment which includes antimicrobial properties designed to support and/or contour the breast(s) or hold a dressing in place after surgical intervention (e.g., thoracic surgery, mastectomy, lumpectomy); |
A |
| 27 |
Antimicrobial postsurgical female underpants |
Intended for use during medical treatment (e.g., chemotherapy) or be used to protect the skin following treatment with a medication (e.g., ointment, cream). It is specifically designed for patient support/comfort in the home or healthcare facility. This is a reusable device. |
A |
| 28 |
Bile duct brachytherapy system applicator, manual |
A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bile duct. It is an individual device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site within the bile duct. |
C |
| 29 |
Bile duct brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the bile duct. |
C |
| 30 |
Bladder brachytherapy system applicator, manual |
A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bladder. |
B |
| 31 |
Bladder brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the bladder. |
C |
| 32 |
Blood photochemical treatment agent |
A sterile photochemical agent (psoralen) intended to be used in conjunction with ultraviolet A (UVA) irradiation to eliminate nucleated cells from blood or blood components (e.g., plasma, leukocyte-enriched blood fraction). |
C |
| 33 |
Brachytherapy radionuclide phantom, test object |
A non-tissue configured model designed to mimic the functional/physical characteristics of normal or diseased human organs during performance evaluations of brachytherapy system components or radiation therapy treatment planning devices. |
A |
| 34 |
Brachytherapy source spacer |
A sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour. |
C |
| 35 |
Brachytherapy system chair |
A mains electricity (AC-powered) device (a chair or stool) that is a component of a brachytherapy system and which is specifically designed to support and position a patient during brachytherapy radiation treatments given by either a manual applicator or a remote afterloading brachytherapy system applicator. It will typically be height-adjustable and may have a reclining back. |
B |
| 36 |
Brachytherapy system remote afterloading source safe |
A component of a remote afterloading brachytherapy system consisting of a shielded vault, and associated source retraction and extrusion mechanisms, alarms, and related mechanical, electronic and software controls, used to shield the brachytherapy sources in order to protect system operators, brachytherapy patients and others from the continuous emissions of the radioactive brachytherapy source(s) when they are not in use. |
C |
| 37 |
Brachytherapy system remote afterloading source transfer tube |
A tube or hose-like catheter with connectors at both ends used to interface the brachytherapy applicator to the remote afterloading system. |
B |
| 38 |
Brachytherapy system remote-afterloading operator console |
A mains electricity (AC-powered) component of a remote-afterloading brachytherapy system intended to function as the primary control panel for the remote afterloader. It typically includes hardware and software that allows for information display and/or transfer, data processing, analysis, and information archiving functions; it may also be intended to interface with other devices (e.g., radiation therapy treatment planning computer) as part of a picture archiving and communication system (PACS). |
C |
| 39 |
Brain brachytherapy system applicator, manual |
A device specifically designed to be used in radiation therapy treatments of the brain. It has individual or modular device configurations designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging guided placement, and removal of single or multiple radioactive sources at a treatment site within the brain. |
D |
| 40 |
Brain brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the brain. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the brain. |
D |
| 41 |
Breast binder |
A strip or roll of fabric or plastic material applied to the breast or breasts for soft tissue support. This is a single-use device. |
A |
| 42 |
Breast brachytherapy system applicator, remote-afterloading |
A sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device. |
C |
| 43 |
Breast transilluminator |
A mains electricity (AC-powered) transilluminating device with a built-in light source using low intensity emissions of visible light and near-infrared radiation (700 to 1050 nm) that is transmitted through the female breast to visualize translucent tissue for the diagnosis of cancer, or other conditions, diseases or abnormalities. This device may also be known as a diaphanoscope. |
D |
| 44 |
Breast ultrasound imaging system |
An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. |
C |
| 45 |
Bronchial brachytherapy system applicator, manual |
A manual brachytherapy applicator specifically designed for temporary use in bronchial radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., endoscopically guided placement, or diagnostic imaging system guided positioning and placement, and removal of single or multiple radioactive sources at the treatment site(s). |
C |
| 46 |
Bronchial brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in bronchial radiation therapy treatments. |
C |
| 47 |
Cervical cone knife |
A surgical, manually-operated, instrument that is inserted into the vagina and designed for excising a sample of abnormal tissue, e.g., indicated by the presence of precancerous changes, from the cervix. |
C |
| 48 |
Cervical cytology scraper, reusable |
A blunt surgical instrument used to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a reusable device. |
A |
| 49 |
Cervical cytology scraper, single-use |
A hand-held, manual, blunt surgical instrument designed to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a single-use device. |
B |
| 50 |
Cervical/intrauterine brachytherapy system applicator, manual |
A manual brachytherapy applicator specifically designed to be used in cervical and/or intrauterine radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging system guided placement, of single or multiple radioactive sources at a treatment site. |
B |
| 51 |
Cervical/intrauterine brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This device includes a wide variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components. |
C |
| 52 |
Class-I biological safety cabinet |
A furniture-like device designed as a partial or total enclosure to provide a class I biosafety level (BSL) to the operator and the environment during the manipulation of microorganisms and other biological hazardous materials. |
B |
| 53 |
Class-II biological safety cabinet |
A furniture-like device designed as a partial or total enclosure to provide a class II biosafety level (BSL) to the operator, the product, and the environment during the manipulation of microorganisms and other biological hazardous materials (usually up to category 3 pathogens) |
C |
| 54 |
Coronary artery brachytherapy system applicator, manual-afterloading |
A sterile flexible tube intended to deliver/remove radiation therapy sources into a coronary artery, typically into the lumen of an implanted stent, as part of a manual-afterloading brachytherapy system. It is introduced into the patient and subsequently connected to the brachytherapy system source transfer device; it includes radiopaque markers to monitor the position of the radiation source. Disposable devices associated with the procedure may be included (e.g., syringe, connectors). This is a single-use device. |
D |
| 55 |
Cytotoxic waste receptacle |
A device designed as a container to allow the safe deposit, collection and storage of cytotoxic materials (e.g., chemotherapy/antineoplastic drugs). |
A |
| 56 |
Elastomeric infusion pump system |
It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device. |
B |
| 57 |
Electroporation therapy system |
A mobile assembly of devices designed to apply electrical impulses to the tissue to enable electroporation, a phenomenon that induces alteration in the structure of cell membranes to increase their permeability and allow molecules that usually cannot enter the cell membrane, such as drugs [electrochemotherapy (ECT)] and genetic materials [electrogenetherapy (EGT)], to reach the cytoplasm. |
C |
| 58 |
Electroporation therapy system endoscopic applicator |
A sterile, patient-contact component of an electroporation therapy system intended to fit onto the distal tip of an endoscope and connect to an electroporation therapy system generator to deliver electrical impulses to tissues during endoscopy as part of electroporation, a phenomenon that induces alteration in the structure of cell membranes to increase their permeability and allow molecules that usually cannot enter the cell membrane, such as drugs [electrochemotherapy (ECT)], to reach the cytoplasm. |
C |
| 59 |
Externally-propelled flexible video colonoscope |
A non-sterile endoscope with a highly flexible sleeve and distal tip intended for the visual examination of the entire adult colon [lower gastrointestinal (GI) tract]. It is used for the screening of colorectal cancer and the detection of other diseases of the lower GI tract. This is a single-use device. |
B |
| 60 |
Extravascular-circulation hyperthermia system |
An assembly of devices designed to produce and control heated fluids circulated within a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body wrap, catheter, probe) for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. |
D |
| 61 |
Extravascular-circulation hyperthermia system applicator, extracorporeal |
A vessel applied to the outside of the body (e.g., in the form of a jacket, vest, body wrap, cushion, blanket, or mattress) that incorporates tubing through which heated fluids are circulated for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. he applicator typically includes a thermometry component that monitors the temperature of the applicator during operation. The applicator includes tubing, cables, and connectors that interface with the hyperthermia system's control unit during treatments. It is typically used in an oncology department. This is a reusable device. |
A |
| 62 |
Extravascular-circulation hyperthermia system applicator, intracorporeal |
A component of a hyperthermia system that typically consists of catheter-enclosed tubing which is introduced into the body either manually or endoscopically. Heated fluid is circulated through the applicator's tubing for localized heating to treat malignant tumours, benign growths, or other disease-related conditions. The applicator (also called an interstitial applicator or probe) typically includes a thermometry component that monitors the temperature of the applicator during operation; it also includes tubing, cables, and connectors that interface with the hyperthermia system's control unit during treatments. It is typically used in an oncology department. This is a single-use device. |
D |
| 63 |
Eye brachytherapy system applicator, manual |
A device in the form of a template that is shielded on one side and containing grooved positions for manual brachytherapy sources on the other used for the temporary topical application of brachytherapy sources to the surface of the eye. |
A |
| 64 |
Facial prosthesis |
An externally-applied device intended to be used as an artificial substitute for parts or sections of the face [e.g., nose, eye(s), eye brows, upper lip] to help restore facial appearance. |
B |
| 65 |
Fixed-aperture therapeutic x-ray system collimator |
A non-automated, x-ray beam-limiting device that is a component of a therapeutic x-ray system and whose opening size/length/shutter assembly is fixed. It is used in radiation therapy applications to limit the effects of scattered radiation and to protect the patient by limiting or eliminating exposure to non-target body areas during treatment. This device is specifically designed for use with an x-ray simulation or therapeutic x-ray system. |
C |
| 66 |
Flexible fibreoptic bronchoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device. |
B |
| 67 |
Flexible fibreoptic colonoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device. |
B |
| 68 |
Flexible fibreoptic duodenoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures and mucous membranes of the duodenum, for conditions like ulcers, polyps and cancers. This is a reusable device. |
B |
| 69 |
Flexible fibreoptic gastroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. It is inserted into the body through the mouth during gastroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in the evaluation or treatment of unusual abdominal pain, bleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia. Physicians may also use the device to obtain biopsies or perform other procedures. This is a reusable device. |
B |
| 70 |
Flexible fibreoptic mediastinoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the mediastinum (the intrapleural space located behind the sternum). It is inserted into the body through an artificial orifice created by an incision made during mediastinoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures such as lymph nodes during a staging evaluation of lung cancer, or to establish the diagnosis of a tumour that is localized to the mediastinum. This is a reusable device. |
C |
| 71 |
Flexible fibreoptic sigmoidoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during the procedure called a sigmoidoscopy or a proctosigmoidoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, polyps. This is a reusable device. |
B |
| 72 |
General-purpose infusion pump, mechanical, single-use |
A portable, non-electric, mechanically-powered device designed to be operated by healthcare professionals for dispensing a single dose of fluid medication (e.g., for antibiotic therapy, chemotherapy, analgesia). It consists of an empty reservoir intended to be filled with medication, a flow-rate regulator and a non-sterile (sterilizable) administration line intended to be connected to an infusion catheter (not included) for intravenous (IV), subcutaneous, intramuscular, or epidural administration. It may include flow and fluid level mechanical indicators and may be worn by the patient in and outside of healthcare settings. This is a single-use device. |
C |
| 73 |
Flexible ultrasound bronchoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device typically through a fibreoptic bundle or a video system, and an ultrasound probe. The probe may be built-in or inserted through a dedicated lumen so that its distal tip is positioned adjacent to that of the endoscope. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device. |
D |
| 74 |
Flexible ultrasound colonoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are typically transmitted to the user by the device through a fibreoptic bundle or a video system and an ultrasound probe. The probe may be integral, or a separate device inserted through a dedicated lumen so that its distal tip is positioned adjacent to that of the endoscope. It is commonly used to examine the lining of the colon, altered bowel habits, colonic cancer, polyps, diverticular disease, and unexplained anaemia. This is a reusable device. |
C |
| 75 |
General-purpose infusion pump, mechanical, reusable |
A non-electric, mechanically-powered (e.g., a spring mechanism) device designed for the continuous or intermittent infusion of medication, typically for antibiotic therapy, chemotherapy, or pain management by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It is primarily designed to be worn by the patient during ambulation in the home. It may be used for patient-controlled analgesia (PCA), and may include mechanical indicators for flow and fluid level status. This is a reusable device. |
C |
| 76 |
Flexible video bronchoscope, reusable |
An endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device. |
B |
| 77 |
Flexible video colonoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device. |
B |
| 78 |
Flexible video colonoscope, single-use |
A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a single-use device. |
C |
| CATEGORY: RADIOTHERAPHY |
|
|
|
| S.NO. |
Name of the product |
Intended Use |
INDIA |
| 1 |
Medical charged-particle radiation therapy system |
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. |
C |
| 2 |
Absorbable perirectal spacer |
An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. |
C |
| 3 |
Absorbable tissue spacer for radiotherapy |
An absorbable material used to reduce radiation exposure of normal tissue during radiotherapy by implanting surgically or percutaneously between tissue, internal organs, etc., to make a space between the malignant tumor and normal tissue. |
D |
| 4 |
Applicator for bile duct manual brachytherapy |
A manual brachytherapy applicator specifically designed for bile duct radiation therapy. An applicator designed to have a configuration that facilitates manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the bile duct. |
C |
| 5 |
Applicator for bladder manual brachytherapy |
A manual brachytherapy applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the bladder. |
C |
| 6 |
Applicator for bladder remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for bladder radiation therapy. It is designed to be temporarily implanted in the bladder. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites. |
C |
| 7 |
Applicator for brachytherapy bile duct remote afterloading |
A remote controlled brachytherapy applicator specifically designed for bile duct radiation therapy. It is designed to be temporarily implanted in the bile duct. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites. |
C |
| 8 |
Applicator for brachytherapy Cervical/endometrial remote afterloading |
A remote controlled brachytherapy applicator specifically designed for uterine cervical or intrauterine radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the uterine cervix and endometrium. |
C |
| 9 |
Applicator for brachytherapy noncentral circulatory general-purpose manual |
A general-purpose brachytherapy applicator used to facilitate radiotherapy. A single or module applicator designed to facilitate manual placement (puncture, local placement, placement under endoscopy, and placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in treatment sites in the non-central circulatory system. |
C |
| 10 |
Applicator for brachytherapy noncentral circulatory general-purpose remote afterloading |
A general-purpose remote controlled brachytherapy applicator used to facilitate radiotherapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites in the non-central circulatory system. |
C |
| 11 |
Applicator for bronchial manual brachytherapy applicator |
A manual brachytherapy applicator specifically designed for temporarily use in bronchial radiation therapy. A single or module applicator designed to facilitate manual placement (placement using an endoscope or positioning, placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites. It may be designed to be standard in configuration or to handle specific radiation sources. |
C |
| 12 |
Applicator for bronchial remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for bronchial radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the bronchus. This device group includes various applicators such as hollow needles, tubes, and catheters, as well as associated devices and connectors. |
C |
| 13 |
Applicator for esophagus manual brachytherapy |
A manual brachytherapy applicator specifically designed for esophagus radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the esophagus. It may be designed to be standard in configuration or to handle specific radiation sources. |
C |
| 14 |
Applicator for esophagus remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for esophagus radiation therapy. It is designed to be temporarily implanted in the esophagus. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources. This device group includes various applicators such as hollow needles, tubes, and catheters, as well as associated devices and connectors. |
C |
| 15 |
Applicator for eye manual brachytherapy |
A template with a groove on the one side. The groove shows the position of the brachytherapy source that is manually, temporarily delivered to the eye surface. The other side is shielded. |
C |
| 16 |
Applicator for manual cervical/endometrial brachytherapy |
A manual brachytherapy applicator specifically designed for uterine cervix or intrauterine radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, placement with an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites. |
C |
| 17 |
Applicator for manual rectal/anal brachytherapy |
A manual brachytherapy applicator specifically designed for rectal and/or anal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the rectum and/or anus. |
C |
| 18 |
Applicator for nasopharynx manual brachytherapy |
A manual brachytherapy applicator specifically designed for nasopharyngeal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, endoscopic placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the nasopharynx. |
C |
| 19 |
Applicator for nasopharynx remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for nasopharyngeal radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the nasopharynx. |
C |
| 20 |
Applicator for neck manual brachytherapy |
A manual brachytherapy applicator specifically designed for neck radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the neck tissues. |
C |
| 21 |
Applicator for neck remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for neck radiation therapy. It is designed to be temporarily implanted in the neck tissues. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources. |
C |
| 22 |
Applicator for pancreas manual brachytherapy |
A manual brachytherapy applicator specifically designed for pancreatic radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, endoscopic placement, or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the pancreas. It may be designed to be standard in configuration or to handle specific radiation sources. |
C |
| 23 |
Applicator for pancreas remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for pancreatic radiation therapy. It is designed to be temporarily implanted in the pancreas. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites. |
C |
| 24 |
Applicator for prostate manual brachytherapy |
A manual brachytherapy applicator specifically designed for prostate radiation therapy. A single or module applicator designed to facilitate manual placement (puncture or placement or removal with a trigger loading device, an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the prostate gland. It may be designed to be standard in configuration or to handle specific radiation sources. |
C |
| 25 |
Applicator for prostate remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for prostate radiation therapy. It is designed to be temporarily implanted in the prostate gland. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources. |
C |
| 26 |
Applicator for rectal/anal remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for rectal or anal radiation therapy. It is designed to be temporarily implanted in the rectum or anus. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources. |
C |
| 27 |
Applicator for tongue manual brachytherapy |
A manual brachytherapy applicator specifically designed for lingual radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the tongue and the surrounding tissues. It may be designed to be standard in configuration or to handle specific radiation sources. |
C |
| 28 |
Applicator for tongue remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for tongue or oral cavity radiation therapy. It is designed to be temporarily implanted in the tongue or the surrounding tissues. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources. |
C |
| 29 |
Applicator for vaginal manual brachytherapy |
A manual brachytherapy applicator specifically designed for vaginal or transvaginal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement, endoscopic placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites. |
C |
| 30 |
Applicator for vaginal remote afterloading brachytherapy |
A remote controlled brachytherapy applicator specifically designed for vaginal or transvaginal radiation therapy. It is designed to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources in the vagina. |
C |
| 31 |
Bile duct brachytherapy system applicator, remote afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the bile duct. It is designed for temporary insertion into the bile duct and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. |
C |
| 32 |
Bladder brachytherapy system applicator, manual |
A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bladder. |
C |
| 33 |
Blood vessel manual brachytherapy applicator |
A manual brachytherapy applicator designed exclusively for blood vessel radiotherapy. Most commonly, it is used to prevent formation of plaque, stenosis and restenosis in blood vessels after surgery. A single or module device designed to facilitate manual placement (placement and removal under endoscopy or using an image diagnostic system) of single or multiple therapeutic radiation sources in the treatment site. |
D |
| 34 |
Blood vessel remote afterloading brachytherapy applicator |
A remote controlled brachytherapy applicator designed exclusively for radiotherapy in blood vessels. This treatment is used to prevent plaque formation and stenosis in blood vessels after surgery. It is designed for temporary implantation in a blood vessel, and serves as a guide for computer-controlled temporary placement and removal of single or multiple therapeutic radiation sources at treatment sites. |
D |
| 35 |
Brachytherapy needle |
A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). |
C |
| 36 |
Brachytherapy radionuclide phantom, anthropomorphic |
A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs. |
C |
| 37 |
Brachytherapy system chair |
A mains electricity (AC-powered) device (a chair or stool) that is a component of a brachytherapy system and which is specifically designed to support and position a patient during brachytherapy radiation treatments given by either a manual applicator or a remote afterloading brachytherapy system applicator. |
B |
| 38 |
Brachytherapy system remote afterloading source safe |
A component of a remote afterloading brachytherapy system consisting of a shielded vault, and associated source retraction and extrusion mechanisms, alarms, and related mechanical, electronic and software controls, used to shield the brachytherapy sources in order to protect system operators, brachytherapy patients and others from the continuous emissions of the radioactive brachytherapy source(s) when they are not in use. |
C |
| 39 |
Brachytherapy system remote afterloading source transfer tube |
The transfer tube, when attached to the applicator and the afterloading system, provides a continuous closed passage that allows for moving either a radioactive source(s) and/or positioning markers from the shielded source storage compartment of the remote afterloading brachytherapy system into appropriate positions within a brachytherapy applicator that has been positioned at a location either on the surface of, or within, the patient. |
C |
| 40 |
Brain brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the brain. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the brain. |
C |
| 41 |
Brain manual brachytherapy applicator |
An applicator specifically designed for brain radiotherapy. A single or module applicator designed to facilitate manual placement (puncture, placement under endoscopy, or placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in the brain. |
D |
| 42 |
Brain remote afterloading brachytherapy applicator |
A remote controlled brachytherapy applicator designed exclusively for brain radiotherapy for temporary implantation in the body. It serves as a computer-controlled guide for temporary placement and removal of a single or multiple therapeutic radiation sources in the brain. |
D |
| 43 |
Breast ductography cannula |
A thin, sterile, semi-rigid or rigid metal tube that is inserted into the nipple of the female breast to inject a contrast medium into the lactiferous ducts to enhance their visualization during a radiographic procedure. |
C |
| 44 |
Central circulatory general-purpose manual brachytherapy applicator |
A single or module applicator designed to facilitate manual placement (puncture, local placement, placement under endoscopy or placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in treatment sites in the central circulatory system. |
D |
| 45 |
Central circulatory general-purpose remote afterloading brachytherapy applicator |
Intended to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites in the central circulatory system. |
D |
| 46 |
Central circulatory manual brachytherapy therapeutic radionuclide system |
A device that places a radiation source manually or automatically at the treatment site in the central circulatory system for providing a required radiation dose during radiotherapy. This device does not equip a remotely controlled radiation source transporter. |
D |
| 47 |
Central circulatory permanent implant manual brachytherapy therapeutic radionuclide source |
A device for the central circulatory system to be placed permanently in the body for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor. The radiation source, which is permanently placed manually, is designed to achieve compatibility with tissues. The radiation source can be selected from the following forms – e.g., microsphere, globe, stent, seed, and wire-in order to generate low-energy photons, beta particles, or alpha particles. |
D |
| 48 |
Central circulatory remote afterloading brachytherapy therapeutic radionuclide source |
A device for the central circulatory system used as radiation source to deliver a high or low dose rate with an afterloading brachytherapy device designed for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor. |
D |
| 49 |
Central circulatory remote afterloading brachytherapy therapeutic radionuclide system |
A device that places a radiation source temporarily at the treatment site in the central circulatory system for providing a required radiation dose during radiotherapy. This device equips a remotely controlled radiation source transporter. |
D |
| 50 |
Central circulatory temporary placement manual brachytherapy therapeutic radionuclide source |
A device for the central circulatory system that uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor, and is placed in the body temporarily, and removed after the pre-determined treatment period. The radiation source, which is temporarily inserted manually, is supplied in various forms – e.g., encapsulated, sealed, plated, foiled, or embedded. |
D |
| 51 |
Compact thermoluminescent dosimetry electrometer |
Thermoluminescence dosimeter (TLD) is used to measure the radiation dose emitted to the phantom, eyes and other organs with high radiosensitivity. |
B |
| 52 |
Conformal Brachytherapy Source |
The intended use of the device is for the treatment of cancer by temporary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. |
C |
| 53 |
High-frequency hyperthermia system |
A system used to generate high-temperatures and to control the provision of heat to the body in the treatment of malignant and benign tumors, or other diseases. |
C |
| 54 |
Intra-vaginal organ positioning device for diagnostic imaging and radiotherapy |
A device that is specifically designed to be inserted in the vagina to properly position and fix the surrounding organs such as uterine cervix, rectum, and urinary bladder for image diagnosis or radiotherapy. This device is used to facilitate reproducible positioning for continuous image examination or continuous radiotherapy. |
B |
| 55 |
Laser irradiation therapy kit |
A kit includes a puncture needle, a guide wire, and a guiding sheath for guiding probes (used for laser irradiation therapy, for example). Not all of the components are included; in some products, two or more of components are integrated into one. |
B |
| 56 |
Light beam patient position indicator |
A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. |
B |
| 57 |
Living tissue radiotherapy system |
A low energy X-ray therapy system designed to treat adjacent tumor lesions with high dose X-rays by placing soft X-ray beams from 5 to 50 kV inside the tumor tissue. It is used in both intraoperative radiation and stereotactic localized radiation therapy. |
C |
| 58 |
Manual radionuclide applicator system |
A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. |
B |
| 59 |
Medical neutron radiation therapy system |
A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy |
C |
| 60 |
MOSFET radiation therapy dosimetry system |
An assembly of devices using metal oxide semiconductor field-effect transistor (MOSFET) technology intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures. Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image-guided radiation therapy, and research. |
C |
| 61 |
Non-central circulatory manual brachytherapy therapeutic radionuclide system |
A device that places a radiation source manually or automatically at the treatment site in the non-central circulatory system for providing a required radiation dose during radiotherapy. |
C |
| 62 |
Non-central circulatory permanent implant manual brachytherapy therapeutic radionuclide source |
A non-central cardiovascular device which is histocompactible and containing an isotope naturally occurring or produced by an accelerator or a nuclear reactor, intended to be permanently implanted in the body for radiation therapy requiring treatment or symptomatic treatment. |
C |
| 63 |
Non-central circulatory remote afterloading brachytherapy therapeutic radionuclide source |
A device for the non-central circulatory system used as radiation source to deliver a high or low dose rate with an after-loading brachytherapy device designed for radiotherapy which is necessary for treatment and symptomatic therapy, and uses natural radioisotopes or radioisotopes produced by an accelerator or a nuclear reactor. |
C |
| 64 |
Non-central circulatory remote afterloading brachytherapy therapeutic radionuclide system |
A device that places a radiation source temporarily at the treatment site in the non-central circulatory system for providing a required radiation dose during radiotherapy. This device equips a remotely controlled radiation source transporter. |
C |
| 65 |
Non-central circulatory temporary placement manual brachytherapy therapeutic radionuclide source |
A non-central cardiovascular device containing an isotope naturally occurring or produced by an accelerator or a nuclear reactor, intended to be temporarily implanted in the body and to be removed after a prescribed duration of treatment. Used in brachytherapy, the device is placed and removed manually or under endoscopic observation. |
C |
| 66 |
Non-powered accelerator system table |
A mechanically-operated bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for radiotherapy that uses a medical linear accelerator or nonlinear accelerator. |
B |
| 67 |
Non-powered neutron therapy table |
A bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses neutron rays that are generated from a nuclear reactor, etc. It is equipped with a table top that fixes the posture, pneumatic control, magnetic lock, crank, and lever for mechanical tabletop positioning control and table height control. |
B |
| 68 |
Radionuclide brachytherapy table |
A programmable bed for electric radiotherapy to adjust the patient's posture and immobilize the patient for treatment that uses an after loading short-distance irradiation treatment apparatus that is operated manually or electrically. |
B |
| 69 |
Non-powered remote irradiation therapy table |
A bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses a remote radionuclide radiotherapy apparatus. |
B |
| 70 |
Non-powered X-rays radiation therapy table |
A bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses an X-ray therapy apparatus. |
B |
| 71 |
Nuclear medicine positron emission tomography system |
A positron emission tomography (PET) system specifically designed to detect, record, quantify, and analyze the pattern of 511-keV photon emissions generated by annihilation from the decay of positron-emitting radiopharmaceuticals. |
C |
| 72 |
Operator radiation protection spectacles |
A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment. |
B |
| 73 |
Patient positioning device for breast diagnostic imaging and radiotherapy |
A device that is specifically designed to properly position and fix a female patient's breasts and chest for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy. |
C |
| 74 |
Patient positioning device for extremity diagnostic imaging and radiotherapy |
A device that is specifically designed to properly position and fix a patient's arms and legs for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy. |
C |
| 75 |
Patient positioning device for pelvis diagnostic imaging and radiotherapy |
The device that consists of frames, plates, or other parts, and is specifically designed to properly position and fix the patient's abdomen and pelvic region for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy. |
B |
| 76 |
Patient positioning device for whole body diagnostic imaging and radiotherapy |
A device that consists of fixed or adjustable parts (e.g., frames and plates), and is specifically designed to properly position and fix the patient's whole body for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy. |
B |
| 77 |
Post Breast Biopsy Hemostatic Breast Compression Device |
A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. |
C |
| 78 |
Powered neutron therapy table |
A programmable bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses neutron rays that are generated from the nuclear reactor, etc. |
B |
| 79 |
Powered patient table for accelerator |
A bed operate by programmable for electric radiotherapy designed to adjust the patient's posture and immobilize the patient for radiotherapy that uses medical linear accelerator or non-linear accelerator. |
B |
| 80 |
Powered radiation therapy patient support assembly |
A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy |
C |
| 81 |
Powered radionuclide brachytherapy table |
A programmable bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses an after loading short-distance irradiation treatment apparatus that is operated manually or electrically. |
B |
| 82 |
Powered remote irradiation therapy table |
A programmable electrically operated bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses a remote cobalt 60 radiotherapy apparatus and other remote radionuclide radiotherapy apparatuses. |
B |
| 83 |
Powered X-rays radiation therapy table |
A programmable electrically operated bed for radiotherapy designed to adjust the patient's posture and immobilize the patient for treatment that uses an X-ray therapy apparatus. |
B |
| 84 |
Radiation therapy beam-shaping block |
A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source |
C |
| 85 |
Radiation therapy simulation system |
A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. |
C |
| 86 |
Radio-frequency ablation system |
A system that heats and cauterizes malignant or benign tumors, etc. with radio wave energy. |
C |
| 87 |
Radio-frequency lesion generator system with probe |
A device that administers a high-frequency electric current (radio frequency) to the internal nerves in order to increase temperature in a controlled way to create a therapeutic lesion. |
C |
| 88 |
Radiographic Protective Glove |
A personnel protective glove is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation |
B |
| 89 |
Radionuclide brachytherapy source |
A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy |
C |
| 90 |
Radionuclide dynamic function testing equipment |
A device used to measure and record temporal variations of radioisotope concentrations in the body. Specialized devices, such as devices for thyroid uptake measurement, renograms, and radioisotope blood volume measurement, are included. |
B |
| 91 |
Radionuclide radiation therapy system |
A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. |
C |
| 92 |
Radionuclide source for remote irradiation therapy |
Radiation sources generated in a reactor and used as in a remote afterloading system designed to deliver a therapeutic radiation beam to a target anatomical area. The radiation sources incorporated as a component of the remote afterloading system are generally sealed. |
C |
| 93 |
Radionuclide system contour detector for remote irradiation therapy |
Intended to precisely determine the outline of the area of the body to be irradiated. Usually, the information obtained from this device is entered into a radiotherapy planning system and utilized for the radiotherapy plan. |
C |
| 94 |
Real-time position management respiratory gating system, optical |
An assembly of electronic devices designed to track the respiratory pattern of a patient by means of optical technology to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. |
C |
| 95 |
Rectal balloon for prostate immobilization |
A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. |
C |
| 96 |
Remote controlled radionuclide applicator system |
A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. |
C |
| 97 |
Stationary radiation protection barrier |
A device for permanent installation that forms a structural barrier that shields or attenuates radiation emitted from primary radiation source or scattered radiation source. |
B |
| 98 |
Stereotactic radiotherapy accelerator system |
A stereotactic radiation therapy system for treatment based on a linear accelerator (or microtron). The device may be used to inactivate lymphocytes. |
C |
| 99 |
X-ray CT system for radiotherapy planning |
A X-ray CT system that has a special configuration, containing hardware, software, etc. used in radiotherapy planning. It is used to determine the size and positioning of the therapeutic radiation field based on a series of treatment parameters to be generated. |
C |
| 100 |
X-ray radiation therapy system |
An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. |
C |
| 101 |
X-ray/CT combined linear accelerator system |
A combined system of a linear accelerator system and an X-ray CT system for radiotherapy planning. |
C |
| 102 |
X-ray/CT combined particle radiotherapy equipment |
A combined system of particle radiotherapy equipment and an X-ray CT system for radiotherapy planning. |
C |
| CATEGORY: Nephrology and Renal Care |
|
|
|
| S.NO. |
Medical Device Name |
Intended Use |
INDIA |
| 1 |
Absorbable peritoneum catheter cuff |
Intended to maintain stable contact between the skin and the peritoneal dialysis catheter, and prevents bacterial invasion from the outlet. It is embedded subcutaneously at the outlet of the peritoneal dialysis catheter. |
D |
| 2 |
Automated peritoneal dialysis system |
An active medical devices intended to perform peritoneal dialysis. |
C |
| 3 |
Urinary stone retrieval basket |
Intended to remove urinary stones (renal calculi) from the body during an endoscopic procedure. |
B |
| 4 |
Chair, Haemodialysis, Electrically powered/Manual |
Intended to support the patient in a seated or reclined posture during haemodialysis procedures. |
A |
| 5 |
Collagen-containing peritoneum absorbable catheter cuff |
A cuff that consists of biodegradable porous material containing collagen, intended to be embedded subcutaneously at the outlet of the peritoneal dialysis catheter. |
D |
| 6 |
Crimp for plier, Haemodialysis |
Intended to manipulate the arteriovenous shunt of patients required hemodialysis. |
A |
| 7 |
Dialyser connector |
Intended to connect between a dialysis fluid circuit and dialyzer, etc. |
B |
| 8 |
Dialysis apheresis unit, Therapeutic |
Intended to filtrate the blood and separates the plasma, and extracts specific substances in the plasma (e.g., LDL cholesterol). Then, the plasma is passed through the filtration column in the device and the specific substances that are combined with various substrates are extracted. |
C |
| 9 |
Disposable Hemoperfusion Cartridge |
Intended in hemoperfusion machine to thoroughly remove the endogenous and exogenous materials such as residual drugs, toxins and metabolic substances in patients by means of adsorption of synthetic resin and extracorporeal blood circulation. |
C |
| 10 |
Electrical conductivity measuring instrument for dialysis fluid |
Intended to determine the concentration of dialysis fluid supplied to a dialyzer based on the measurement of electrical conductivity of dialysis fluid (usually, it is electrically measured). |
C |
| 11 |
Flexible fibreoptic nephroscope |
Intended for the visual examination of internal structures and treatment of the kidney (e.g., renal calculi) by inserting percutaneously into the renal pelvis during nephroscopy. |
B |
| 12 |
Haemodialyzer reprocessing system |
Intended to clean (including rinsing, cleaning, testing, and record-keeping of process) and disinfect haemodialysis dialyzers after each use so that they can be reused. |
C |
| 13 |
Haemofilters |
A filter used in the process of haemofiltration, to allow for the removal of toxins and/or the replacement of electrolytes. |
C |
| 14 |
Hemodiafiltration system |
A device used for blood purification with a hemodiafilter. |
C |
| 15 |
Hemodialysis blood tubing/Extracorporeal systems for blood purification |
Sterilized blood tubing intended for hemodialysis (including hemofiltration and hemodiafiltration). |
B |
| 16 |
Hollow-fibre haemodialysis dialyser |
Hollow fiber filter intended to remove impurities/fluid from the blood of a patient via haemodialysis machine. |
C |
| 17 |
Kidney donor-organ preservation/transport system |
A dedicated system designed to support and maintain a donated kidney organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient. |
C |
| 18 |
Kidney stone filter |
A filter intended to be placed in the urinary duct to prevent a renal stone from moving from the kidney into the bladder. |
C |
| 19 |
Laser lithotripsy fibre/suction guide |
Intended to function as a channel for insertion of the laser fibre of a laser beam guide (e.g., of a general/multiple surgical laser system) in nephroscope, and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. |
B |
| 20 |
Multi-patient dialysis fluid delivery system |
Intended to prepare dialysis fluid for hemodialysis. |
C |
| 21 |
Peritoneal dialysis catheter adaptor |
Intended to connect (devices of different makers and makes devices compatible with each other) a catheter for peritoneal lavage to an external device that manages dialysates. |
C |
| 22 |
Peritoneal dialysis catheter guidewire |
A guidewire used temporarily for correction of the position of a peritoneal dialysis catheter. |
B |
| 23 |
Peritoneal dialysis dialysate warmer |
Intended to heat the dialysate to within one degree of kidney patient who is on continuous ambulatory peritoneal dialysis (CAPD), body temperature prior to infusion. |
C |
| 24 |
Peritoneal dialysis ultraviolet irradiation unit |
Intended for ultraviolet irradiation of components of peritoneal dialysis transfer tube set. |
B |
| 25 |
Reverse Osmosis Unit (for dialysis) |
Intended to be used with haemodialysis to produce water through reverse osmosis with quality suitable for use with hemodialysis equipment. |
C |
| 26 |
Rigid nephroscope |
Intended for visual examination, diagnosis, and treatment of the kidney, renal pelvis, major calyces, and minor calyces by percutaneously inserting scope into the renal pelvis. |
B |
| 27 |
Shunt thrombus suction set |
A set used to suction a thrombus developing inside an arteriovenous shunt (external shunt) during procedures including hemodialysis. |
B |
| 28 |
Portable continuous peritoneal perfusate thermal conditoner |
A device that heats the peritoneal perfusate before injection into the peritoneal cavity. The perfusate is usually heated through direct contact of the dialysis fluid bag with the radiant heat source. |
B |
| 29 |
Citric acid haemodialysis system cleaning cartridge |
Intended for the in-line preparation of a citric acid solution to clean/disinfect the fluid pathways of the system (remove calcium and magnesium deposits) in combination with a heat disinfection program. |
B |
| 30 |
Extracorporeal circuit waste bag |
Intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. |
B |
| 31 |
Haemodialysis concentrate |
Intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels while haemodilysis is performed. |
C |
| 32 |
Haemodialysis conductivity standard solution |
Intended to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate, and water treatment systems used with haemodialysis delivery systems. |
C |
| 33 |
Haemodialysis dialysate water chlorine test kit/strip |
Intended to be used to rapidly indicate, through colour change, the concentration of total chlorine in water used to prepare dialysate solution for haemodialysis. |
B |
| 34 |
Haemodialysis system air/foam detector |
Intended to identify air bubbles and/or foam in blood returned to the body [usually through an arteriovenous fistula (AVF)] by the extracorporeal blood circuit of a haemodialysis system. |
C |
| 35 |
Haemodialysis system bicarbonate mixer |
Intended to mix two concentrates, A and B, plus water, to the dialysis solution (dialysate) and monitors the mixture. |
C |
| 36 |
Haemodialysis system central monitor |
Device intended to connect with multiple haemodialysis systems in order to aid monitoring several dialysis treatments simultaneously. |
C |
| 37 |
Haemodialysis system plasma filtration unit |
An electrically-powered integral unit of a haemodialysis system that allows for the removal of plasma from the blood and the infusion of an equal amount of plasma replacement solution to the blood. |
C |
| 38 |
Peritoneal dialysis system dialysate filter |
A microporous device used to capture contamination particles of the dialysate before its instillation into the peritoneal cavity. |
C |
| 39 |
Sodium carbonate haemodialysis system cleaning cartridge |
Intended to be connected to the fluid circuit of an institutional haemodialysis system for the in-line preparation of a sodium carbonate solution to clean the fluid pathways of the system (remove organic deposits, fats, proteins) in combination with a heat disinfection program. |
C |
| CATEGORY: Software Medical Devices |
|
|
|
| S.NO. |
Name of Product |
Intended Use |
IMDR |
| 1 |
Continuous Glucose Monitor Retrospective Data Analysis Software |
Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device. |
A |
| 2 |
Continuous Glucose Monitor Secondary Display |
The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. |
B |
| 3 |
Insulin Pump Secondary Display |
The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. |
B |
| 4 |
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors. The device is software with a graphical user interface. |
C |
| 5 |
Coronary Vascular Physiologic Simulation Software |
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease by performing offline analysis of pre-existing imaging data to simulate blood flow in the coronary vasculature. |
C |
| 6 |
Multivariate Vital Signs Index |
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs. Collects measured parameter inputs and automates the calculation of a summary index based on those parameters. |
B |
| 7 |
Electrocardiograph Software for Home Use |
Device intended for home use which creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. |
B |
| 8 |
Photoplethysmograph Analysis Software for Home Use |
Photoplethysmograph analysis software device for home analyzes of photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a clinical diagnosis. |
B |
| 9 |
Angiographic Coronary Vascular Physiologic Simulation Software |
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease. |
C |
| 10 |
Software For Visualization Of Vascular Anatomy And Intravascular Devices |
Visualization and measurement of blood vessels and intravascular devices for preoperational planning. |
C |
| 11 |
Orthodontic Software |
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. |
C |
| 12 |
Dental Abutment Design Software For Dental Laboratory |
The software device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. |
C |
| 13 |
Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease |
The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests. |
B |
| 14 |
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid |
Intended as an aid to provide an interpretation of the patient's neuropsychiatric condition. |
C |
| 15 |
Normalizing Quantitative Electroencephalograph Software |
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified clinical user. |
C |
| 16 |
Index-Generating Electroencephalograph Software |
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified clinical user. |
C |
| 17 |
Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization. |
C |
| 18 |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified clinical user. |
C |
| 19 |
Automatic Event Detection Software For Full-Montage Electroencephalograph |
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified clinical user. |
C |
| 20 |
Computerized Cognitive Assessment Aid For Concussion |
For use as an assessment aid in the management of concussion. |
C |
| 21 |
Ataxiagraph With Interpretive Software |
Device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed and provides interpretation or clinical implication of the measurement. |
B |
| 22 |
Computerized Behavioral Therapy Device For Psychiatric Disorders |
The device is intended to provide cognitive behavioral therapy to treat substance use disorder. The device is a software-based mobile app downloaded onto a smartphone. |
C |
| 23 |
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
A traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain. |
C |
| 24 |
Device, Fertility Diagnostic, Contraceptive, Software Application |
Designed to monitor and provide fertility information to prevent pregnancy (contraception). |
C |
| 25 |
Diabetic Retinopathy Detection Device |
A retinal diagnostic software device is a software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. |
C |
| 26 |
Colon Computed Tomography System, Computer Aided Detection |
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review. |
B |
| 27 |
Lung Computed Tomography System, Computer-Aided Detection |
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. |
B |
| 28 |
Chest X-Ray Computer Aided Detection |
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review. |
B |
| 29 |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
Assist clinical users in characterizing lesions identified on acquired medical images. |
C |
| 30 |
Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). |
B |
| 31 |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography, MR, CT, ultrasound, radiography). |
C |
| 32 |
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
X-ray angiographic imaging based coronary vascular simulation software device is a device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. And yields simulation-based metrics for certain cardiology applications which aid clinical user. |
B |
| 33 |
Automated Radiological Image Processing Software |
To provide automated radiological image processing and artificial intelligence based analysis tools. |
B |
| 34 |
Image Acquisition And/Or Optimization Guided By Artificial Intelligence |
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. |
B |
| 35 |
Burn Resuscitation Decision Support Software |
The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn. |
C |
| 36 |
Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. |
C |
| 37 |
Software for peritoneal dialysis treatment |
A software that performs prescription simulation of peritoneal dialysis based on the results obtained from a peritoneal function test (PFT), a peritoneal equilibration test (PET) and a body composition analyzer. It supports preparation of a dialysis treatment plan. |
C |
| 38 |
Software for radiation planning |
A software that calculates and displays the area to be treated with radiation and the internal dose distribution based on the results obtained with CT systems etc., and supports the radiotherapy planning. |
C |
| 39 |
Software for radiotherapy QAQC planning |
A software that verifies the validity of the radiotherapy plan by recalculation of the dose and the MU value calculated with the radiotherapy planning system software and radiotherapy planning system. |
C |
| 40 |
Software for ophthalmic surgery treatment planning |
A software for intended to aid ophthalmic surgical planning based on measurement of the eye prior to the surgery. It simulates surgical results. |
C |
| 41 |
Software for active implanted device control |
A software used to transmit one or more electrical operating characteristics noninvasively to the active base unit and change the characteristics. |
C |
| 42 |
Information collating software for radiotherapy |
A software that has function of collating the information such as irradiation parameter specified by a radiation planning software, and the condition that a radiotherapy equipment irradiates, on the occasion of the irradiation of X-ray in the radiotherapy. |
C |
| 43 |
Software for gene variants analysis (for cancer genome profiling) |
A software for gene variants analysis which is designed to perform cancer genome profiling based on information of gene variants obtained from body tissue samples. |
C |
| 44 |
Supporting software for differential diagnosis with endoscopic imaging |
A software, which is designed to process data obtained from an endoscopic image. The resultant data are provided for diagnostic, etc. It has functions to output numeric values and graphs based on quantitative data such as benign/malignant differentiation of lesion candidates, presenting candidates of diagnostic outcomes, and stage of disease progression. |
C |
| 45 |
Chairside dental CAD/CAM unit |
Intended for computer-aided design (CAD) or computer-aided manufacturing (CAM) of dental restorations. |
B |
| 46 |
Software for using with mammography-combined diagnostic X-ray system |
A software, which is designed to processes data obtained from a combined diagnostic mammography-radiography system. |
B |
| 47 |
Software for public thoracic and abdominal health screening diagnostic X-ray system |
A software, which is designed to process data obtained from a thoracic and abdominal public health screening diagnostic X-ray system. The resultant data are provided for diagnosis, etc. This term may involve the recording media where the software are stored. |
B |
| 48 |
Software for visual evoked response stimulator |
A software, which is designed to process data obtained from a visual evoked response stimulator. The resultant data are provided for diagnosis, etc. |
B |
| 49 |
Software for auditory evoked response stimulator |
A software for medical device, which is designed to process data obtained from an auditory evoked response stimulator. The resultant data are provided for diagnosis, etc. |
B |
| 50 |
Software for pulmonary exercise stress monitoring system |
A software, which is designed to process data obtained from a pulmonary exercise stress monitoring system. |
B |
| 51 |
Software for ECG recorder with real-time analysis |
A software, which is designed to process data obtained from an ECG recorder with real-time analysis. The resultant data are provided for diagnosis, etc. |
B |
| 52 |
Software for film-recorded digital radiography |
A software, which is designed to process data obtained from a film-recorded digital radiography. The resultant data are provided for diagnosis, etc. |
B |
| 53 |
Software for dye dilution cardiac output calculator |
A software, which is designed to process data obtained from a dye dilution cardiac output unit. The resultant data are provided for diagnosis, etc. |
B |
| 54 |
Software for urodynamic measurement system |
A software, which is designed to process data obtained from a urodynamic measurement system. The resultant data are provided for diagnosis, etc. |
B |
| 55 |
Software for vestibular function caloric stimulator |
A software, which is designed to process data obtained from a vestibular function caloric stimulator. The resultant data are provided for diagnosis, etc. |
B |
| 56 |
Supporting software for external fixators treatment plan |
A software that analyzes information useful for bone fracture and for correction of bone deformities based on information collected from diagnostic X-ray systems, etc. or based on information entered in a therapeutic apparatus, and supports preparation of a treatment plan with external fixators. |
B |
| 57 |
Diagnostic supporting software for diabetes |
A software that supports analysis and assessment of therapeutic effects of diabetes treatment by processing information collected from a blood glucose meter, etc into the data related to changes or trends in blood glucose levels. |
B |
| 58 |
Quantitative calculation software for IGC test |
A software that performs quantitative calculation of blood flow in relation to a brightness time change based on information obtained from video images of indocyanine green angiography. |
B |
| 59 |
Analyzing software for hemodynamics or cardiac function |
A medical device program that analyzes hemodynamics or cardiac function based on information obtained from diagnostic imaging systems, etc. and uses the results for diagnosis. |
B |
| 60 |
Supporting software for root canal treatment |
A software for medical device, which is used to support preparation of a treatment plan based on information collected from diagnostic imaging systems, etc. in the root canal treatment. |
B |
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