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_b2d533b846d8393157e20842e7a46156. 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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Brand Name
BiPAP A40
License Holder
PHILIPS INDIA LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
The BiPAP A40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (BiPAP A40) with Obstructive Sleep Apnea (BiPAP A40), Respiratory Insufficiency, or Respiratory Failure. It is intended to be used in home, institutional/hospital, and portable applications such as wheelchairs and gurneys. It is not intended to be used as a transport ventilator, and is not intended for life support
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