Silicone Gel Adhesive Composite Hydrocellular Foam Dressing - India CDSCO Medical Device Registration

Silicone Gel Adhesive Composite Hydrocellular Foam Dressing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000151_0012f114d52c82604f4c73fedce60fac_e717954293db303fa1f4d9832df1a557. This device is marketed under the brand name OPSITE. The license holder is Smith & Nephew Healthcare Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Silicone Gel Adhesive Composite Hydrocellular Foam Dressing

UID: IMP/MD/2019/000151_0012f114d52c82604f4c73fedce60fac_e717954293db303fa1f4d9832df1a557

Brand Name

OPSITE

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

1. Wound management by secondary intention on shallow, granulating wounds, chronic and acute exudative wounds, full and partial thickness wounds including: • Pressure ulcers • Leg ulcers • Diabetic Foot Ulcers • Surgical wounds • First and second degree burns • Donor sites • Skin tears • Fungating Ulcers Can be used in conjunction with INTRASITE™ GEL for necrotic or sloughy wounds. 2. Pressure ulcer prevention on intact skin as part of a pressure ulcer prevention protocol.