CPAP/BPAP ORAL MASK - India CDSCO Medical Device Registration

CPAP/BPAP ORAL MASK is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000783_af1ee466609bc9423eb7d3b47280e846_52f95110a566f284f1930395f29aceed. This device is marketed under the brand name ISO 9360. The license holder is VENTICARE MEDICAL INC, and it is classified as Device Class Class B. The approving authority is Tamil Nadu.

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CDSCO Registered

Class Class B

CPAP/BPAP ORAL MASK

UID: MFG/MD/2023/000783_af1ee466609bc9423eb7d3b47280e846_52f95110a566f284f1930395f29aceed

Brand Name

ISO 9360

License Holder

VENTICARE MEDICAL INC

Device Class

Class B

Approving Authority

Tamil Nadu

Product Information

A device designed to be fitted to the user's mouth to interface with a continuous positive airway pressure (ISO 9360) or bi-level positive airway pressure (ISO 9360) unit to provide the respiratory tract with direct ambient air, or medical oxygen (ISO 9360) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (ISO 9360)