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/2018/000111_a5401db954f3f81262cc02b03b853190_d75fa4b623a9ff8342127c3649c072a8. This device is marketed under the brand name OptiSite Arterial Perfusion Cannula. The license holder is Edwards Lifesciences (India) Private Limited,, 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/2018/000111_a5401db954f3f81262cc02b03b853190_d75fa4b623a9ff8342127c3649c072a8

Brand Name

OptiSite Arterial Perfusion Cannula

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Carpentier – Edwards Physio Tricuspid Annuloplasty Ring, is intended for use in patients with tricuspid insufficiency, to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus

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Annuloplasty Ring

Brand: Mosaic

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

Class D

Annuloplasty Ring

Brand: Mosaic

Class D

Annuloplasty Ring

Brand: Mosaic

Class D

Brand: OptiSite Arterial Perfusion Cannula

Edwards Lifesciences (India) Private Limited,

Class D

Brand: Fem-Flex II™ Femoral Arterial Cannula

Class D