Hemoclip - India CDSCO Medical Device Registration

Hemoclip is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000341_8e201271ccc6fa7123ce68f53d9e0e18_a1de56a5207a60f4c588da1fa2542db0. This device is marketed under the brand name Percutaneous Endoscopic Gastrostomy. The license holder is Biorad Medisys Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Hemoclip

UID: MFG/MD/2022/000341_8e201271ccc6fa7123ce68f53d9e0e18_a1de56a5207a60f4c588da1fa2542db0

Brand Name

Percutaneous Endoscopic Gastrostomy

License Holder

Biorad Medisys Pvt Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for a) Mucosal/sub-mucosal defects 3 cm b) Bleeding ulcers c) Arteries 2mm d) Polyps 1.5cm in diameter e) Diverticula in the colon 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4. As a supplementary method, closure for GI tract luminal perforations 20 mm that can be treated conservatively.