CDSCO risk classification
Respiratory medical device classification
Every respiratory device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 20 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 86
- Class A
- 31
- Class B
- 46
- Class C
- 8
- Class D
- 0
Respiratory devices and their class
86 devices
Activated-oxygen generator
Respiratory
Class BIt is a device that makes activated oxygen (singlet oxygen) which is mixed with room air and produces activated water as a by-product.
AI-based Respiratory Sound Analysis and Monitoring Software, patient-use
Respiratory
Class CAn artificial intelligence (AI)-based interpretive software program intended to be used by a layperson (non-clinically trained) for noninvasive screening and triage of respiratory diseases [e.g., lower respiratory tract disease, restrictive airway disease, etc.] through the analysis of recorded respiratory sounds (e.g., coughing), verbal cues provided by the patient and other collected patient data (vitals such as SpO2, temperature, demographics/medical history). It typically creates a risk score or probability for the urgency of medical attention required by the user and may or may not monitor adult and pediatric population presenting with respiratory symptoms. It is not intended to provide a definitive diagnosis or replace professional clinical judgment.
Argon gas analyser
Respiratory
Class BAn instrument intended to measure the concentration (partial pressure) of argon (Ar) in a gas mixture sample to aid in determining a patients ventilatory status.
Artificial airway tube cuff pressure monitor
Respiratory
Class BA 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.
Bronchography Catheter
Respiratory
Class BIntended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or
Bronchoscopic specimen collection chamber
Respiratory
Class AA sterile, noninvasive container intended for the collection/sampling, and preservation and/or transport, of respiratory specimens during a bronchoscopic procedure [e.g., bronchoalveolar lavage (BAL), etc.], for subsequent microbiological analysis. It is designed to be attached to a bronchoscope. It does not contain additives. This is a single-use device.
Bulk oxygen concentration system
Respiratory
Class AAn 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.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Cardiopulmonary resuscitation mask
Respiratory
Class AA device that intended to be placed over a patients mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR).
Cardiopulmonary resuscitation mask, reusable
Respiratory
Class ANon-sterile, non-measuringA flexible, form-shaped device that is placed over a patients mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). It is not intended to connect to an active device. The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross- contamination. This is a reusable device.
Cardiopulmonary resuscitation mouthpiece/cover
Respiratory
Class ANon-sterile, non-measuringA non-sterile device that consists of a mouthpiece with an integrated face/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (CPR) to prevent cross-contamination between patient and CPR administrator. This is a single- use device.
Cerebral oximeter
Respiratory
Class BA device used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a patient.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Cervical Drain
Respiratory
Class BThe device is used to avoid postoperative wound and respiratory complications such as excessive edema, hematoma, infection, re-intubation, delayed extubation, or respiratory distress.
Chest-oscillation airway secretion-clearing system
Respiratory
Class BDevices 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.
Chest-percussion airway secretion-clearing system
Respiratory
Class BDevices 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.
Closed Suction System
Respiratory
Class BIt is intended for endotracheal suctioning to provide a patient airway by removing excess fluids, secretions, exudates and transudate through the artificial airway.
Cold-air diagnostic inhalation system
Respiratory
Class BAn assembly of devices intended to be used in the assessment of a pateint suffering from asthma.
Cough long-term ambulatory recording system
Respiratory
Class AAn assembly of devices intended for long-term detection and recording of the number of times a patient coughs during daily activities or sleep.
CPAP Device
Respiratory
Class BA portable, powered device intended to assist noninvasive ventilation using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA) and not dependent on ventilator; it may also be intended to treat snoring. This is a reusable device intended for use in homecare or health care settings.
CPAP/BPAP unit ambient air filter
Respiratory
Class not statedA non-sterile filter intended to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air; it is not intended to filter medical gases or microbes.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Cricothyrotome
Respiratory
Class BA 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.
Diagnostic Spirometer
Respiratory
Class BA device designed to measure several or all respiratory- gas volume and flow parameters needed to evaluate basic pulmonary function.
Dry powder inhaler
Respiratory
Class ANon-sterile, non-measuringA hand-held device designed to administer powdered medicine through the mouth and into the bronchial airways.
Dry Powder Inhaler, with Inhalation Monitor
Respiratory
Class BA portable, battery-powered device intended for self-administration of powdered medicine through the mouth and into the bronchial airways, and simultaneous i) monitoring of the user's inhalation flow rates and "firing" coordination during administration, and ii) detection of when a dose of inhaled medication has been taken. It may transmit the acquired data wirelessly to a web-based or mobile software application for display of information acquired by the integrated sensor and self-management of medications doses. It may also indicate whether the drug has been adequately pricked/pierced to ensure that all medication is inhaled by the user. It does not recommend drug doses or calculate the amount of dose administered to a user.
Dry salt therapy device
Respiratory
Class ANon-sterile, non-measuringA 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.
Electroacoustical airway secretion-clearing system
Respiratory
Class BAn 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.
Emergency Airway Needle
Respiratory
Class BEmergency airway puncture is the placement of a hollow needle through the throat into the airway. It is done to treat life-threatening choking.
Endotracheal tube introducer
Respiratory
Class AA device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation
Exhaled-gas oesophageal intubation detector
Respiratory
Class AA 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.
Filter adapter (Spirometry accessory)
Respiratory
Class ANon-sterile, non-measuringIntended to connect a filter with different spirometers.
Foetal pulse oximeter
Respiratory
Class BA 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.
Gas pipeline/supply system air compressor
Respiratory
Class BA device designed to create compressed medical grade air, and supply it to a hospital or institution's gas pipeline/supply system for patient use.
Heated respiratory humidifier
Respiratory
Class BA 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.
Home-use sleep apnoea recording system
Respiratory
Class BA device intended to continuously measure and record patient physiological parameters during sleep in the home, to facilitate the diagnosis of sleep apnoea.
Hook, surgical, tracheal
Respiratory
Class ANon-sterile, non-measuringA manual surgical instrument intended to hold the trachea steady during the creation of a tracheostoma and/or for separating/drawing aside the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. This is a reusable device.
Hyperbaric chamber
Respiratory
Class CThe intended use of the Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient.
Hypopnea sensor/alarm
Respiratory
Class BAn 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.
Impedance pneumography recording/analysis system
Respiratory
Class BAn assembly of electronic devices intended for continuous recording of a patient’s pulmonary function parameters using impedance pneumography (IP).
Implantable sleep apnoea treatment system
Respiratory
Class CAn assembly of devices intended for home management of obstructive sleep apnoea (OSA) using an implanted stimulator to provide electrical stimulation to the hypoglossal nerve.
Incentive Spirometer, Measuring
Respiratory
Class AA hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of lung collapse and to help facilitate airway opening and clearing. It may be used to determine/monitor the maximum volume of gas which can be inspired.
Infant apnoea monitor
Respiratory
Class BA 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).
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Infant CPAP stabilizing cap/strap
Respiratory
Class ANon-sterile, non-measuringIntended for use as a stabilizing head strap/cap as an accessory of infant nasal CPAP respiratory support breathing system (CPAP system not included).
Integrated Patient Airway Secretion System
Respiratory
Class CAn Internet-of-Things (IoT)-enabled, powered device intended for use in the management of airway secretions (including deep lung cleaning) in adult patients requiring invasive mechanical ventilation in hospital ICU settings, i.e., used in settings/manner that may be potentially hazardous to the patient if it does not operate properly. The device automates the suctioning of tracheal, subglottic, and oral secretions at physician-prescribed intervals and pressures.
Manual chest percussor
Respiratory
Class BA 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.
Manual Pulmonary Resuscitator, single-use
Respiratory
Class BA non-powered, manually-operated device intended to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically includes a hand-ventilated flexible chamber, a gas reservoir, tubing, and a connector for attachment to a mask/endotracheal (ET) tube. It may connect to an oxygen source. This is a single-use device.
Medical Air Compressor
Respiratory
Class BA non-invasive, powered device intended to generate medical-grade, filtered, dry compressed air for direct supply to compressed air-dependent respiratory devices such as ventilators, etc. for eventual infusion into the patient. This is not a patient bedside device, and it does not directly administer medical air/gas to the patient.
Medical Gas Flowmeter with Humidification Chamber, reusable
Respiratory
Class BA collection of devices intended for use in conjunction with medical gas sources (e.g., oxygen cylinders, etc.) [not included], consisting of a medical gas flowmeter that measures and regulates the flow of a medical gas during therapeutic interventions and a humidification chamber that contains water for the purpose of humidifying respiratory gases. This is a reusable device.
Monitoring Spirometer
Respiratory
Class BA device designed to measure continuously a patients tidal volume or minute volume for the evaluation of the patients ventilatory status.
Nasal Oxygen Catheter
Respiratory
Class BIt is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.
Nasopharyngeal Catheter/ Nasopharyngeal
Respiratory
Class BA catheter (for adults) passed through the nares and advanced to the depth of the nasopharynx to remove air choke or obstruction. AResuscitator.
Nitrogen monoxide analyser
Respiratory
Class BA device intended to measure nitric oxide (NO), in exhaled air to facilitate diagnosis and management of asthma.
Nitrous oxide analyser
Respiratory
Class BAn 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.
Nose clip (Spirometry accessory)
Respiratory
Class ANon-sterile, non-measuringIntended to plug nostrils during spirometric analysis
Oropharyngeal airway, reusable
Respiratory
Class ANon-sterile, non-measuringIntended to be inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a reusable device.
Oxygen Concentrator
Respiratory
Class BA device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2 to patient.
Oxygen mask respiration indicator
Respiratory
Class ANon-sterile, non-measuringIntended to be attached to the exhalation vent hole on the exterior of a standard oxygen face mask and provide visual (qualitative) indication of patient respiration. It does not have measuring function.
Portable Oxygen Generator
Respiratory
Class CA powered device intended to generate medical-grade oxygen electrolytically at the point-of-care for infusion to hypoxemic individuals during emergency situations (e.g., pre-ambulatory, pre-hospital settings, low-access settings) as a means to sustain life. It may be accompanied with delivery tubing and oxygen mask. It is intended for use by both clinicians and laypersons.
Public respirator (2 ply, 3 ply face mask)
Respiratory
Class ANon-sterile, non-measuringA 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.
Pulmonary function analysis system
Respiratory
Class BA device used to measure the function of the respiratory system in adults and compliant children.
Pulse oximetry telemetric monitoring system
Respiratory
Class BAn assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location for viewing.
Respiratory apnoea monitoring system
Respiratory
Class BAn 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).
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Shield, resuscitation
Respiratory
Class ANon-sterile, non-measuringTo minimise tissue contact and exchange of fluids between parties during mouth to mouth resuscitation.
Steam inhaler
Respiratory
Class AAn 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.
Stress test treadmill
Respiratory
Class AA device used as a component of a stress test system that permits the evaluation of a patients physiologic response to physical stress.
Therapeutic air ionizer
Respiratory
Class AA 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.
Therapeutic positive pressure breathing ventilator
Respiratory
Class CA device used for therapeutic rehabilitation of patients with chronic respiratory diseases, and for the distribution of aerosolized pharmacological agents to the patients airways and lungs.
Thoracic bioconductance measurement system
Respiratory
Class BAn 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.
Thoracic electrical impedance segmentography system
Respiratory
Class BAn 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.
Thoracic electrical impedance tomography system
Respiratory
Class CAn 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.
Thoracic suction pump
Respiratory
Class BA 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.
Tongue-adjustment sleep apnoea treatment system
Respiratory
Class BAn 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.
Tracheal (Endotracheal) Tube
Respiratory
Class BInserts the tube with the help of a laryngoscope, an instrument that permits to see the upper portion of the trachea, just below the vocal cords.
Tracheal prosthesis
Respiratory
Class CIt is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree.
Tracheal surgery dilator, reusable
Respiratory
Class ANon-sterile, non-measuringIntended 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. This is a reusable device.
Tracheobronchial suction catheter
Respiratory
Class BClearing the airways of mucus, pus, or aspirated materials to improve oxygenation and ventilation.
Tracheostoma protective filter
Respiratory
Class AA device designed as a filter for protecting a stomal opening in the windpipe against harmful external influences.
Tracheostoma protector
Respiratory
Class ANon-sterile, non-measuringA 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.
Tracheostoma shower shield
Respiratory
Class ANon-sterile, non-measuringA non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering.
Tracheostomy Mask
Respiratory
Class BA device intended to deliver oxygen or a mixture of oxygen and air to a patient who has a tracheostomy airway. It is connected to an oxygen/medical air source with tubing and is constructed of plastic. The device can be used over a tracheal tube or stoma. This is a sterile, single-use device.
Tracheostomy tube holder
Respiratory
Class ANon-sterile, non-measuringIntended to secure a patient’s tracheostomy tube for use on pediatric (neonates, infants and children) patients.
Tracheostomy tube lubricant
Respiratory
Class ANon-sterile, non-measuringA 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.
Tracheostomy tube neck holder, single-use
Respiratory
Class ANon-sterile, non-measuringA non-sterile device intended to secure a tracheostomy tube by fastening around the neck of the patient.
Tracheostomy Tube/Tracheal Tube
Respiratory
Class BA breathing tube inserted into a tracheotomy used to obtain a closed circuit for ventilation.
Transcutaneous blood gas monitoring system
Respiratory
Class BAn assembly of devices designed for the continuous and transcutaneous measurement of a patients blood gas parameters detected through the jugular vein (SjvO2).
Valsalva manoeuvre mouthpiece
Respiratory
Class ANon-sterile, non-measuringA device intended to be inserted into a patients mouth to facilitate performance of the Valsalva manoeuvre.
Video intubation laryngoscope handle/monitor
Respiratory
Class ANon-sterile, non-measuringA 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.
Whole-body plethysmograph
Respiratory
Class BA graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function.
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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