Soft silicone wound contact layer - India CDSCO Medical Device Registration

Soft silicone wound contact layer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000494_64ce352ceddfeccf968a4757ccf50c29_70894449feb867d1961a3f1624f2db52. This device is marketed under the brand name Mepilex Border Lite. The license holder is M/s Molnlycke Healthcare India 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

Soft silicone wound contact layer

UID: IMP/MD/2020/000494_64ce352ceddfeccf968a4757ccf50c29_70894449feb867d1961a3f1624f2db52

Brand Name

Mepilex Border Lite

License Holder

M/s Molnlycke Healthcare India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Mepitel One is a wound contact layer designed for the management of a wide range of exuding wounds such as; skin tears, skin abrasions, surgical incisions, partial thickness burns, traumatic wounds, partial and full thickness grafts, radiated skin, leg and foot ulcers. It can also be used as a protective layer on non-exuding wounds, blisters and on areas with fragile skin