Ventilator - India CDSCO Medical Device Registration

Ventilator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000553_e389d4f3b37832447b737284e4e71268_b4883c349ae9694c3518f85a434975b5. This device is marketed under the brand name BiPAP A40. The license holder is PHILIPS INDIA LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Ventilator

UID: IMP/MD/2023/000553_e389d4f3b37832447b737284e4e71268_b4883c349ae9694c3518f85a434975b5

Brand Name

BiPAP A40

License Holder

PHILIPS INDIA LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional, home, and nonemergency transport settings for example wheelchair, or personal vehicle. It may be used for both invasive and noninvasive ventilation. The AVAPS-AE mode is intended for noninvasive use in adult and pediatric patients weighing over 10kg with Obstructive Sleep Apnea (BiPAP A40), Respiratory Insufficiency and Respiratory Failure.

Class C

Brand: OmniLab Advanced +

Class B