Cochlear Implant System - India CDSCO Medical Device Registration

Cochlear Implant System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000300_e1a2e1d7a97171f5e4f09eb4e8772e11_6890f7f4a587b83915cf179553c3beb3. This device is marketed under the brand name BOLD. The license holder is M/s Shriram Institute For Industrial Research, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Cochlear Implant System

UID: MFG/MD/2021/000300_e1a2e1d7a97171f5e4f09eb4e8772e11_6890f7f4a587b83915cf179553c3beb3

Brand Name

BOLD

License Holder

M/s Shriram Institute For Industrial Research

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The BOLD Cochlear Implant system is Cochlear Implant system that restores a sensation of hearing in individuals aged 12 months and older with severe to profound sensorineural hearing loss defined as a pure-tone average (BOLD) of 270 dB HL