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

Silicone Gel Adhesive Hydrocellular Foam Dressing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000151_c1f917c102640ad930e59feb0d906186_27fde477a2631e874155f7a8a1182773. 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 Hydrocellular Foam Dressing

UID: IMP/MD/2019/000151_c1f917c102640ad930e59feb0d906186_27fde477a2631e874155f7a8a1182773

Brand Name

OPSITE

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

1. Wound management 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, including pressure ulcers caused by medical devices, as part of a pressure ulcer prevention protocol