MADSEN® Alpha OAE Screener - India CDSCO Medical Device Registration

MADSEN® Alpha OAE Screener is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000393_0369b9c38b1a88adee0955344ecf737e_76388178abef07bde9ad7d9850ba6f56. This device is marketed under the brand name Aurical® Freefit. The license holder is Genworks Health Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

MADSEN® Alpha OAE Screener

UID: IMP/MD/2023/000393_0369b9c38b1a88adee0955344ecf737e_76388178abef07bde9ad7d9850ba6f56

Brand Name

Aurical® Freefit

License Holder

Genworks Health Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (Aurical® Freefit) necessary for the diagnosis of auditory and hearing-related disorders

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Aurical® Aud

Brand: Aurical® Freefit

Genworks Health Private Limited

MADSEN® Alpha OAE Screener - India CDSCO Medical Device Registration

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Approving Authority

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