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/2018/000012_8e201271ccc6fa7123ce68f53d9e0e18_6975e1b3b7e1db8fac5be2a7ccd955da. This device is marketed under the brand name Genius. 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/2018/000012_8e201271ccc6fa7123ce68f53d9e0e18_6975e1b3b7e1db8fac5be2a7ccd955da

Brand Name

Genius

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 <3cm 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 <20mm that can be treated conservatively

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Hemoclip

Brand: Percutaneous Endoscopic Gastrostomy

Biorad Medisys Pvt Ltd

Class C

Brand: Genius

GENIUS ORTHO PVT LTD

Class C

Brand: Morcellator

Class B