Hydrophilic Polyurethane Wound dressing - India CDSCO Medical Device Registration

Hydrophilic Polyurethane Wound dressing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000151_d3b64f2ac4dc4ba75830189e209d1130_8c2b4772a540865ad9f5f6f3f07f5d89. 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

Hydrophilic Polyurethane Wound dressing

UID: IMP/MD/2019/000151_d3b64f2ac4dc4ba75830189e209d1130_8c2b4772a540865ad9f5f6f3f07f5d89

Brand Name

OPSITE

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Wound management, by secondary intention of chronic and acute full thickness, partial thickness or shallow granulating exuding wounds, such as pressure ulcers, leg ulcers, diabetic foot ulcers, malignant wounds, surgical wounds, first and second degree burns, donor sites and fungating ulcers. ALLEVYN Non-Adhesive may be used on infected wounds. Where the product is used on infected wounds the wounds should be treated as per local clinical protocol. ALLEVYN Non Adhesive can be used under compression. ALLEVYN Non-Adhesive can be used in conjunction with INTRASITE™ Gel for necrotic or sloughy wounds. ALLEVYN Heel is suitable for dressing heels and other awkward areas and contributes to a pressure relieving protocol when used in conjunction with pressure relieving devices. For pressure and leg ulcers with moderate to heavy exudate. ALLEVYN Non-Adhesive can even be used under compression. ALLEVYN Heel is suitable for dressing heels and other awkward areas