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Foam Dressing - India CDSCO Medical Device Registration

Foam Dressing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000299_bf2f048b632c86aa92832a5c95db177e_fae5c4543496fff1120ee6cd0b076be8. This device is marketed under the brand name Biatain Silicone Lite. The license holder is Coloplast India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
Foam Dressing
UID: IMP/MD/2018/000299_bf2f048b632c86aa92832a5c95db177e_fae5c4543496fff1120ee6cd0b076be8

Brand Name

Biatain Silicone Lite

Device Class

Class C

Approving Authority

CDSCO

Product Information

Biatain Foam Dressings are indicated for a wide range of exuding wounds including leg ulcers and pressure ulcers. Biatain Foam Dressings may be used for second-degree burns, postoperative wounds and skin abrasions. Biatain Non-Adhesive Foam Dressings are also indicated for non-infected diabetic foot ulcers. Biatain Non-Adhesive and Adhesive Foam Dressings are also indicated for donor sites. Biatain Foam Dressings may be used on patients who are in treatment for a local or systemic infection at the discretion of a physician. Biatain Foam Dressings may be used throughout the healing process to provide protection for the types of wounds indicated. Biatain Foam Dressings are suitable for use in combination with compression therapy. Biatain Foam Dressings and Biatain Foam Filler/Cavity may be used together with Purilon Gel for effective autolytic debridement of necrotic tissue. Biatain Foam Filler/Cavity is indicated for deep exuding wounds, including leg ulcers, pressure ulcers, non-infected diabetic foot ulcers and acute wounds

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