Self-adherent soft silicone foam dressing - India CDSCO Medical Device Registration

Self-adherent soft silicone foam dressing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000494_47127bacbdf89d86d1f385bc8c30f9f1_1cd1db1ce8f5aecb083384b38db351c2. 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

Self-adherent soft silicone foam dressing

UID: IMP/MD/2020/000494_47127bacbdf89d86d1f385bc8c30f9f1_1cd1db1ce8f5aecb083384b38db351c2

Brand Name

Mepilex Border Lite

License Holder

M/s Molnlycke Healthcare India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Mepilex Border and Mepilex Border Sacrum: Mepilex Border is designed for a wide range of exuding wounds such as pressure ulcers, leg and foot ulcers and traumatic wounds e.g. skin tears and surgical wounds. Mepilex Border can also be used on dry/necrotic wounds in combination with gels. Mepilex Border reduces postoperative blistering, and may also be used as part of a prophylactic therapy to help prevent skin damages, e.g. pressure ulcers. Mepilex Border Sacrum and Heel : Mepilex Border is designed to be part of a prophylactic therapy to prevent skin damage, e.g. pressure ulcers and to reduce postoperative blistering. Mepilex Border is also designed for a wide range of exuding wounds such as pressure ulcers, leg ulcers, foot ulcers, traumatic wounds (Mepilex Border Lite) and surgical wounds. Mepilex Border can also be used on dry/necrotic wounds in combination with gels