MAMMARY IMPLANT SILICONE GEL - SMOOTH SURFACE - India CDSCO Medical Device Registration

MAMMARY IMPLANT SILICONE GEL - SMOOTH SURFACE is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001013_db3bfc1c24d0c71dcc082523af98b0fe_76160f3d8769d2e9041d77684d951635. This device is marketed under the brand name Silimed. The license holder is NK Healthcare Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

MAMMARY IMPLANT SILICONE GEL - SMOOTH SURFACE

UID: IMP/MD/2023/001013_db3bfc1c24d0c71dcc082523af98b0fe_76160f3d8769d2e9041d77684d951635

Brand Name

Silimed

License Holder

NK Healthcare Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

Mammary Implants - SILIMED Silicone Gel achieve the intended purpose in the following ways: - In case of breast augmentation: increase in the volume and circumference of one or both breasts; - In the case of breast reconstruction: return of the volume and circumference of one or both breasts removed after mastectomy or trauma, or which did not develop due to any medical abnormality. The SILIMED mammary implant is a single use product, implantable through invasive surgery and its medical grade silicone elastomer composition and polyurethane foam coating, when applicable, come into contact with the tissues of the mammary region, aiming at a prolonged use of the implant