Absorbent, gelling, fibrous dressing - India CDSCO Medical Device Registration

Absorbent, gelling, fibrous dressing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000566_14b2ae60f3bd83125f9f88a39bf8ce47_a9c7114b417e400ef0fadd60500fb5b6. This device is marketed under the brand name IV3000. 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

Absorbent, gelling, fibrous dressing

UID: IMP/MD/2020/000566_14b2ae60f3bd83125f9f88a39bf8ce47_a9c7114b417e400ef0fadd60500fb5b6

Brand Name

IV3000

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

DURAFIBER is indicated as an absorbent, gelling dressing for the management of chronic and acute, full thickness, partial thickness, or shallow granulating exuding wounds. For example: leg ulcers; pressure ulcers; diabetic ulcers; surgical wounds; wounds left to heal by secondary intent; donor sites; tunneling and fistulae wounds; partial thickness burns; traumatic wounds; and wounds that are prone to bleeding such as wounds that have been surgically or mechanically debrided. DURAFIBER is designed to be left in place for up to 7 days.