CDSCO risk classification
Anesthesiology medical device classification
Every anesthesiology device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 34 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 147
- Class A
- 75
- Class B
- 54
- Class C
- 16
- Class D
- 2
Anesthesiology devices and their class
147 devices
Adaptor, luer, non-sterile
Anesthesiology
Class ANon-sterile, non-measuringNon-invasive adapters which connect or stopper enteral feeding tubes.
Aerosol delivery tubing
Anesthesiology
Class AA 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.
Aerosol face mask
Anesthesiology
Class BA 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 patients airway.
Aerosol inhalation monitor
Anesthesiology
Class BIt is a device that enables a medical professional t objectively assess in detail how the test subject uses their inhaler.
Airway device cleaning utensil
Anesthesiology
Class ANon-sterile, non-measuringA hand-held device intended to be used to clean an in situ and ex situ airway device.
Airway pressure alarm
Anesthesiology
Class AA device connected to the breathing circuit that monitors a patients upper airway pressure during assisted mechanical ventilation.
Airway pressure/oxygen monitor
Anesthesiology
Class BIt is 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.
Airway protection face mask
Anesthesiology
Class AA flexible, form-shaped device that is placed over the nose and mouth to provide respiratory protection.
Airway temperature monitoring system
Anesthesiology
Class BAn assembly of devices used to continuously measure the temperature at a specific point along a ventilation airway.
Airway tube forceps
Anesthesiology
Class AA 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.
Airway tube forceps, reusable
Anesthesiology
Class ANon-sterile, non-measuringIntended 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.
Anaesthesia breathing circuit
Anesthesiology
Class BAn assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient.
Anaesthesia catheter Luer connector
Anesthesiology
Class AIt is a device intended to create a mechanical union between an anaesthesia catheter and an external device, via a Luer connection.
Anaesthesia catheter Luer connector, non-sterile
Anesthesiology
Class ANon-sterile, non-measuringIntended to create a mechanical union between an anaesthesia catheter and an external device.
Anaesthesia depth monitor
Anesthesiology
Class BIt is 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.
Anaesthesia depth simulator
Anesthesiology
Class AA 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.
Anaesthesia instrument table
Anesthesiology
Class ANon-sterile, non-measuringIt is intended as a support for Anaesthesia instruments used during general anaesthesia surgical procedures.
Anaesthesia mask stabilizer
Anesthesiology
Class ANon-sterile, non-measuringA 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.
Anaesthesia system leakage tester
Anesthesiology
Class ANon-sterile, non-measuringA device intended to test an anaesthesia system for leakage.
Anaesthesia tube holder, non-sterile
Anesthesiology
Class ANon-sterile, non-measuringThe intended purpose for this device is for holding and supporting respiration tubing and breathing circuits connected to a patient, to prevent disconnection. This is a noninvasive device.
anaesthesia vaporizer
Anesthesiology
Class CA device used to vaporize the anaesthetic agent and deliver a controlled amount of the agent to a patient being prepared for surgery.
Anaesthesia warmer
Anesthesiology
Class AA device intended to warm the anaesthetic solutions prior to it being administered to a patient for anaesthesia.
Anaesthesia workstation gas scavenger
Anesthesiology
Class BA 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.
Anaesthetic Conduction Kit
Anesthesiology
Class CAn anaesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anaesthesia. The device may contain syringes, needles, and drugs.
Anaesthetic Conduction Needle
Anesthesiology
Class BAn anaesthesia conduction needle is a device used to inject local anaesthetics into a patient to provide regional anaesthesia.
Anaesthetic gas absorption/desorption device
Anesthesiology
Class BA device intended to, when integrated within the common line of a breathing circuit, absorb and desorb (i.e., recycle) exhaled volatile anaesthetic agents.
Anaesthetic gas scavenging terminal unit
Anesthesiology
Class AA device intended to function as an outlet assembly to which the operator can connect/disconnect an anaesthetic gas scavenging system (AGSS).
Anesthesia Face Mask
Anesthesiology
Class AA device designed to be placed over a patient's nose and/or mouth to administer anaesthetic gases to the upper airway.
Anesthesia machine
Anesthesiology
Class CA 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.
Anesthetic Conduction Catheter
Anesthesiology
Class BAn anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.
Anesthetic Conduction Filter
Anesthesiology
Class CA microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
Artificial airway stylet
Anesthesiology
Class AA 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.
Artificial airway stylet, reusable
Anesthesiology
Class ANon-sterile, non-measuringA 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. It is withdrawn after intubation has been completed. This is a reusable device.
Artificial airway washing/disinfection jar
Anesthesiology
Class BA container intended to hold artificial airway devices to facilitate their washing/disinfection.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Atomizer
Anesthesiology
Class AA device that is intended to provide liquid medication in aerosolized form into the air that a patient will breathe.
Atomizer, non-ventilatory
Anesthesiology
Class ANon-sterile, non-measuringA non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. This does not have a measuring function (non-graduated).
Brachial plexus anaesthesia kit
Anesthesiology
Class BA collection of devices intended to deliver a brachial plexus nerve block through one of several routes that could include supraclavicular, interscalene, infraclavicular, or axillary.
Breathing circuit bag
Anesthesiology
Class AA device intended to store breathing gas during the respiratory cycle.
Breathing circuit catheter mount, single-use
Anesthesiology
Class BA non-powered device intended to connect to a respiratory circuit (e.g., ventilator or anesthesia machine, etc.) or a resuscitator with endotracheal/tracheostomy tube to enable increased mobility at the patient end of the circuit or connections. This is a single-use, short-term use device.
Breathing circuit condenser
Anesthesiology
Class AA 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.
Breathing circuit dryer
Anesthesiology
Class AA device that is used for the purpose of drying breathing circuit equipment that have been washed inorder to prevent bacteria growth and deterioration
Breathing circuit equipment dryer / drying chamber
Anesthesiology
Class ANon-sterile, non-measuringA device that is used for the purpose of drying breathing circuit equipment that have been washed in order to prevent bacteria growth and deterioration. This is not intended for disinfection and does not have a measuring function.
Breathing circuit gas- sampling/monitoring set
Anesthesiology
Class BA 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.
Breathing circuit washer/disinfector
Anesthesiology
Class BA device intended for the cleaning and high-level disinfection of breathing circuit components used in respiratory therapy and anaesthesia equipment.
Breathing mouthpiece
Anesthesiology
Class AA device intended to be inserted into a patient's mouth to facilitate access to the respiratory system.
Bronchial cannula
Anesthesiology
Class AA tube-shaped surgical instrument that is inserted into the lumen of the bronchus by means of a trocar blade to provide rigidity.
Bronchoscope
Anesthesiology
Class AAn 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.
Bronchoscopy tube
Anesthesiology
Class CA 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.
Bulk oxygen concentration system
Anesthesiology
Class BAn 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.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Capnography oxygen mask
Anesthesiology
Class AA 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.
Capnography sampling adaptor
Anesthesiology
Class ANon-sterile, non-measuringThe device is intended for sampling CO2 and use with monitors enabled with capnography technology .
Carbon Dioxide (CO2) Absorbent
Anesthesiology
Class BA non-sterile, single-use carbon dioxide (CO₂) absorbent intended to be incorporated into the absorber assembly of a compatible anaesthetic breathing system to chemically remove carbon dioxide from the patient’s exhaled respiratory gases during closed or semi-closed circuit anaesthesia, thereby reducing CO₂ accumulation in the breathing circuit.
Carbon dioxide monitor
Anesthesiology
Class CA 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.
Continuous Flush Catheter
Anesthesiology
Class BIntended for the controlled and selective infusion of
CPAP/BPAP chin strap, reusable
Anesthesiology
Class ANon-sterile, non-measuringA non-sterile device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during positive airway pressure (PAP) therapy to control mouth air leaks by gently holding the mouth closed.
CPAP/BPAP chin strap,single use
Anesthesiology
Class ANon-sterile, non-measuringA non-sterile, disposable device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during positive airway pressure (PAP) therapy to control mouth air leaks by gently holding the mouth closed.
CPAP/BPAP nasal mask
Anesthesiology
Class BA 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).
CPAP/BPAP oral mask
Anesthesiology
Class BA 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).
Electronic epidural space locator control unit
Anesthesiology
Class DA 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.
Electronic oesophageal stethoscope
Anesthesiology
Class BAn 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.
Endobronchial airway sizing kit
Anesthesiology
Class AA 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).
Endotracheal secretion monitoring system
Anesthesiology
Class BAn 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.
Endotracheal tube holder
Anesthesiology
Class ANon-sterile, non-measuringA non-sterile device intended to provide a reliable stabilization of endotracheal tube (not included) after intubation.
Endotracheal tube introducer, reusable
Anesthesiology
Class ANon-sterile, non-measuringIntended to help with the insertion of an endotracheal (ET) tube (not included) into the airways of a patient during intubation. This is a reusable device.
Epidural anaesthesia kit
Anesthesiology
Class CA collection of devices intended to be used to deliver an analgesic or anaesthetic agent to the epidural space for pain management.
Epidural Needle
Anesthesiology
Class BIntended for transient delivery of anasthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
Gas sampling line filter, reusable
Anesthesiology
Class ANon-sterile, non-measuringA screening device intended to be installed in a reusable gas sampling line or gas measuring instrument (not included) to remove moisture, from the gas, to help minimize damage to the measuring instrument from gas condensation. It does not have a measuring function.
General-gas low pressure tubing, reusable
Anesthesiology
Class ANon-sterile, non-measuringIntended to deliver nitrogen or instrument air to the console from the wall in the hospital. This does not include measuring devices.
Handgrip cover for laryngoscope
Anesthesiology
Class ANon-sterile, non-measuringIntended to be placed over a reusable laryngoscope device during intubation to create a barrier in order to reduce the cleaning time and turnaround time of the laryngoscope blade for reuse.
Heat and moisture exchange/filter
Anesthesiology
Class BIt is intended to use for airway management by anaesthesia/respiratory care department.
Helium/oxygen breathing gas mixer
Anesthesiology
Class BAn 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.
High-frequency ventilator
Anesthesiology
Class CA 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.
In-line arterial blood sampling set
Anesthesiology
Class AA collection of devices designed to obtain an in-line arterial blood specimen while maintaining a closed system.
In-line backflow valve
Anesthesiology
Class AA general-purpose device used in medical tubing or pipe- lines to prevent the backflow of gases or liquids.
In-line backflow valve, reusable
Anesthesiology
Class ANon-sterile, non-measuringA general-purpose device intended to be used in medical tubing or pipelines to prevent the backflow of gases or liquids. This is a reusable device.
Infusion line clamp
Anesthesiology
Class ANon-sterile, non-measuringA non-sterile device intended for the clamping of medical tubes.
Infusion line securement clip, single-use
Anesthesiology
Class ANon-sterile, non-measuringThe device is intended to hold tubing to avoid kinking of the tube during infusion and patient moving.
Inhalational analgesia unit
Anesthesiology
Class BA device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation.
Intracardiac oximeter
Anesthesiology
Class BA 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.
Intravascular blood gas/pH monitoring system
Anesthesiology
Class BAn 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.
Intravascular membrane oxygenator
Anesthesiology
Class CA 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.
Intravascular oximeter
Anesthesiology
Class BAn instrument designed for the continuous in vivo measurement of venous blood oxygen saturation (SvO2) using a fibreoptic catheter.
Intubation laryngoscope
Anesthesiology
Class AA 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.
Intubation laryngoscope, reusable
Anesthesiology
Class ANon-sterile, non-measuringA 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. This is a reusable device intended to be sterilized prior to use. This device does not have any additional functional uses.
Intubation teeth protector
Anesthesiology
Class ANon-sterile, non-measuringA device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures.
Invasive arterial pressure cardiac output/oximetry monitor
Anesthesiology
Class BA 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.
Laryngeal airway
Anesthesiology
Class AA 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.
Laryngeal airway introducer
Anesthesiology
Class AA 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.
Laryngeal airway introducer, reusable
Anesthesiology
Class ANon-sterile, non-measuringA non-sterile 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. This is a reusable device intended to be sterilized prior to use.
Laryngectomy tube
Anesthesiology
Class BA 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.
Laryngoscope blade, reusable
Anesthesiology
Class ANon-sterile, non-measuringA component of a laryngoscope (i.e., non- endoscopic rigid type) that is intended to be inserted 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. It may be MR- compatible. This is a reusable device.
Laryngoscope blade, single-use
Anesthesiology
Class AA sterile, disposable component of a laryngoscope (i.e., non-endoscopic rigid type) that is intended to be inserted 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. This is a single-use device.
Laryngotracheal anaesthesia applicator
Anesthesiology
Class BA 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.
Manual jet ventilation device
Anesthesiology
Class CA 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.
Mask strap
Anesthesiology
Class ANon-sterile, non-measuringA head strap intended to hold and stabilise a CPAP or BiPAP face mask onto a patients face.
Mechanical positive pressure airway secretion- clearing device
Anesthesiology
Class ANon-sterile, non-measuringA 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.
Medical gas flowmeter
Anesthesiology
Class AA device intended to measure and regulate the flow of a medical gas during various procedures.
Medical gas flowmeter, Thorpe tube
Anesthesiology
Class AA device intended to measure and regulate the flow of a medical gas during various procedures.
Medical gas pipeline system
Anesthesiology
Class AAn assembly of devices designed to supply compressed medical gases from a central source to endpoints throughout a medical facility.
Medical gas pipeline system automatic outlet analyser
Anesthesiology
Class AA mains component of a medical gas pipeline supply system that monitors the composition of a gas delivered from the supply system.
Medical gas pipeline system pressure monitor
Anesthesiology
Class AA 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.
Medical gas terminal unit
Anesthesiology
Class AA 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 medica device.
Medicine chamber spacer
Anesthesiology
Class ANon-sterile, non-measuringA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patients mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles.
Microbial medical gas filter
Anesthesiology
Class BA screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy.
Nasopharyngeal airway
Anesthesiology
Class BA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency.
Negative-pressure ventilator
Anesthesiology
Class CAn 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.
Neonatal chest percussor
Anesthesiology
Class BA 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.
Nerve-block injection manometer
Anesthesiology
Class AA 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.
Nitric oxide delivery unit
Anesthesiology
Class BA 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.
Non-heated respiratory humidifier
Anesthesiology
Class BA 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.
Non-rebreathing oxygen face mask
Anesthesiology
Class AA flexible, form-shaped device designed with valve to control rebreathing and contamination of gas, placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patients airway for oxygen therapy.
Nose clip
Anesthesiology
Class ANon-sterile, non-measuringA 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.
Oropharyngeal airway
Anesthesiology
Class AA 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.
Oxygen administration hood
Anesthesiology
Class ANon-sterile, non-measuringA 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 patients O2 uptake.
Oxygen saturation/pulse rate simulator
Anesthesiology
Class AAn 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.
Oxygen/air breathing gas mixer
Anesthesiology
Class BA portable mechanical device designed to mix air and oxygen (O2) for mobile O2 administration during first aid or emergency situations.
Oxygen/air/nitrous oxide breathing gas mixer
Anesthesiology
Class CAn device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing.
Patient physiologic monitoring system
Anesthesiology
Class CAn assembly of devices designed for continuous assessment of several vital physiologic parameters of patient(s).
Peak flow meter
Anesthesiology
Class BA 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.
Pleural manometer
Anesthesiology
Class BA noninvasive device intended to convert pressure into electrical signals for the measurement of pressure within the pleural cavity.
Pneumatic chest percussor
Anesthesiology
Class BA 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.
Pressure algometer/aesthesiometer
Anesthesiology
Class BAn instrument designed to measure a patients sensitivity to pain (pain threshold) and tactile sensibility.
Pulmonary function analysis system
Anesthesiology
Class BA device used to measure the function of the respiratory system in adults and compliant children.
Pulmonary resuscitator
Anesthesiology
Class CA hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration.
Pulse Co-oximeter
Anesthesiology
Class BA device designed to detect hypoxia via the transcutaneous multiwave measurement and display of carboxy-haemoglobin saturation (SpCO) and typically other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), and haemoglobin concentration (SpHb).
Pulse oximeter
Anesthesiology
Class CA device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2).
Rebreathing oxygen face mask
Anesthesiology
Class AA flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patients airway.
Respiration monitor
Anesthesiology
Class BA device designed to measure and display a non- ambulatory patients 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).
Respiratory Humidification Chamber, single-use
Anesthesiology
Class BA device intended to be used in conjunction with respiratory humidifier, breathing circuits, etc., [not included] to contain water for the purpose of humidifying respiratory gases. This is a single-use device.
Respiratory oxygen monitor
Anesthesiology
Class BAn instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting.
Respiratory oxygen therapy monitor/regulator
Anesthesiology
Class BAn 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.
Retrograde endotracheal intubation kit
Anesthesiology
Class BA collection of devices used to assist in the placement of an endotracheal (ET) tube during difficult/emergency airway access procedures
Rigid non-bladed video intubation laryngoscope
Anesthesiology
Class AA non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation.
Rigid non-bladed video intubation laryngoscope, reusable
Anesthesiology
Class ANon-sterile, non-measuringA non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. This is a reusable device intended to be sterilized prior to use.
Saddle block anaesthesia kit
Anesthesiology
Class BA 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.
Spirometer/pulmonary function analyser syringe
Anesthesiology
Class AA 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.
Tracheal surgery dilator
Anesthesiology
Class AA 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.
Tracheostomy kit
Anesthesiology
Class CA 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.
Tracheotome
Anesthesiology
Class AA surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy).
Tracheotome, reusable
Anesthesiology
Class ANon-sterile, non-measuringA surgical instrument intended to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy). This is a reusable device intended to be sterilized prior to use.
Ultrasonic cough stimulation system
Anesthesiology
Class AAn 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.
Ultrasonic respiratory humidifier
Anesthesiology
Class BA 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.
Vacuum-assisted airway secretion-clearing system
Anesthesiology
Class BA 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.
Ventilator Breathing Circuit
Anesthesiology
Class BA non-powered assembly of devices intended to deliver air or oxygen (O2)-enriched gases and/or additional gases [e.g., nitrous oxide (N2O)] from a ventilator [not included], or other air-delivery equipment (e.g., exsufflator), to a patient. It typically includes breathing tubes, a Y-piece connector, and connections for humidifiers, thermoregulatory equipment and monitoring equipment. This may be a reusable/single-use device.
Venturi oxygen face mask
Anesthesiology
Class BA flexible, cone-shaped device placed over the patients nose and mouth to deliver a mixture of an almost precise ratio of air and oxygen to the patients 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.
Video laryngoscope adaptor
Anesthesiology
Class ANon-sterile, non-measuringIntended to serve as a connection between the laryngoscope and the display/monitoring device during intubation.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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