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Full Face Mask - India CDSCO Medical Device Registration

Full Face Mask is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000505_743339abd3aebd7dc54e3b628a0c7c7a_0802dce1dc64aa34a45782a16cf7dd92. This device is marketed under the brand name 850 Family. The license holder is Fisher & Paykel Healthcare India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Full Face Mask
UID: IMP/MD/2021/000505_743339abd3aebd7dc54e3b628a0c7c7a_0802dce1dc64aa34a45782a16cf7dd92

Brand Name

850 Family

Device Class

Class B

Approving Authority

CDSCO

Product Information

The F&P Simplus Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus Full Face Mask is intended for Single Paitent Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses

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