Annuloplasty Ring - India CDSCO Medical Device Registration

Annuloplasty Ring is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000517_a5401db954f3f81262cc02b03b853190_e7d77815720806c4b44d1d3814ff89a3. This device is marketed under the brand name Mosaic . The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Annuloplasty Ring

UID: IMP/MD/2020/000517_a5401db954f3f81262cc02b03b853190_e7d77815720806c4b44d1d3814ff89a3

Brand Name

Mosaic

License Holder

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Duran AnCore annuloplasty ring are indicated for the reconstruction or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis

DJ Fang

MedTech Regulatory Expert

Class B

Strata

Brand: Strata NSC Valve

Class C

L/P Shunts

Brand: CSF-Lumboperitoneal Catheter System

Class D