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_2a617113f4f322f120dd7310d118d37b. 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_2a617113f4f322f120dd7310d118d37b

Brand Name

BiPAP A40

License Holder

PHILIPS INDIA LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The BiPAP A40 EFL ventilator is intended to provide non-invasive ventilatory support to treat patients weighing over 10 kg (BiPAP A40) with Obstructive Sleep Apnea (BiPAP A40) or Respiratory Insufficiency. It is intended to be used within the home, institutional/hospital, and diagnostic laboratory environments. This device is not intended for life support. It is not intended to be used as a transport ventilator. The BiPAP A40 EFL screening and therapy is intended for patients weighing over 30 kg (BiPAP A40) with Obstructive Sleep Apnea (BiPAP A40), or Respiratory Insufficiency with primary cause being Chronic Obstructive Pulmonary Disease (BiPAP A40) to screen for the presence, and abolishment of Expiratory Flow Limitation

Class C

Brand: OmniLab Advanced +

Class B