Silver-coated antimicrobial barrier dressing - India CDSCO Medical Device Registration

Silver-coated antimicrobial barrier dressing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000566_8486b048e7eccdea543f2fc4fb8b0d0f_6c5298d7d661d56e2e9257f16c21097c. This device is marketed under the brand name ACTICOAT FLEX 3. The license holder is Smith & Nephew Healthcare 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

Silver-coated antimicrobial barrier dressing

UID: IMP/MD/2020/000566_8486b048e7eccdea543f2fc4fb8b0d0f_6c5298d7d661d56e2e9257f16c21097c

Brand Name

ACTICOAT FLEX 3

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

ACTICOAT is indicated as an absorbent antimicrobial barrier dressing over partial and full thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, burns, and recipient graft sites. ACTICOAT may be used on infected wounds. Where the product is used on infected wounds the infection should be inspected and treated as per local clinical protocol. ACTICOAT may be slit and used as a wound contact layer in combination with Negative Pressure Wound Therapy (ACTICOAT FLEX 3) for a period of up to 3 days.