Auditory Brainstem Implant System - India CDSCO Medical Device Registration

Auditory Brainstem Implant System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000150_39552007d2ad385bb7e1e291a2f3a5a0_deb3499cf1a3e7109d5eb21ed43899fb. This device is marketed under the brand name Sonata Ti100. The license holder is Med-el India Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Auditory Brainstem Implant System

UID: IMP/MD/2019/000150_39552007d2ad385bb7e1e291a2f3a5a0_deb3499cf1a3e7109d5eb21ed43899fb

Brand Name

Sonata Ti100

License Holder

Med-el India Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Intended to evoke auditory sensation by stimulation of the cochlear nucleus (Sonata Ti100) in patients with non-functional cochlear nerves and restore some degree of hearing in individuals who suffer from profound hearing impairment

Class D

Bone Conduction Implant

Brand: Sonata Ti100

Med-el India Private Limited

Class D

Brand: MED-EL

Class C