MAMMARY IMPLANT SILICONE GEL – POLYURETHANE FOAM COATED SURFACE - India CDSCO Medical Device Registration

MAMMARY IMPLANT SILICONE GEL – POLYURETHANE FOAM COATED SURFACE is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001013_ece2f7f9e65d18ec6e2bfa1fd1ce2ad6_f32643a970dd6c3dbebb28408b02f8d5. 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 – POLYURETHANE FOAM COATED SURFACE

UID: IMP/MD/2023/001013_ece2f7f9e65d18ec6e2bfa1fd1ce2ad6_f32643a970dd6c3dbebb28408b02f8d5

Brand Name

Silimed

License Holder

NK Healthcare Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

SILIMED Silicone Gel Mammary Implants achieve their intended purpose in the following ways: - in case of breast enlargement: increased 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 not developed due to any medical abnormality. SILIMED Mammary Implant is a single-use product implantable through invasive surgery and its medical grade silicone elastomer composition and polyurethane foam lining, where applicable, come into contact with breast tissues for a prolonged use of the implant.