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_2cf0abe0a7bc188c257f63c25ba4f854. 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_2cf0abe0a7bc188c257f63c25ba4f854

Brand Name

ACTICOAT FLEX 3

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

ACTICOAT Flex 7 is indicated as an antimicrobial barrier dressing over partial and full thickness wounds such as burns, surgical sites, pressure ulcers, venous ulcers and diabetic ulcers. ACTICOAT Flex 7 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 Flex 7 may be used as a wound contact layer in combination with Negative Pressure Wound Therapy (ACTICOAT FLEX 3) for a period of up to 3 days