Bone Conduction Implant Implant Kit - India CDSCO Medical Device Registration

Bone Conduction Implant Implant Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000150_6fe87c04d7335f8fb9e017895d26ff02_82f6a0d987329d6eebb014516bb0f5fa. 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

Bone Conduction Implant Implant Kit

UID: IMP/MD/2019/000150_6fe87c04d7335f8fb9e017895d26ff02_82f6a0d987329d6eebb014516bb0f5fa

Brand Name

Sonata Ti100

License Holder

Med-el India Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The BONEBRIDGE system with the Bone Conduction Implant BCI 602 is intended to treat patients with either conductive or mixed hearing loss or patients suffering from single-sided sensorineural deafness. The BONEBRIDGE with the BCI 602 augments hearing by providing acoustic information to the inner ear via bone conduction. This is achieved by actuating a vibratory transducer, which is implanted in the temporal bone

Class D

Bone Conduction Implant

Brand: Sonata Ti100

Med-el India Private Limited

Class D

Brand: Sonata Ti100

Class D