Annuloplasty Ring with Holder - Mitral - India CDSCO Medical Device Registration

Annuloplasty Ring with Holder - Mitral is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000111_dc6c27d84a91622189f8522e723837cd_88c4b47dfaf842c349f31804e78d0d58. 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 with Holder - Mitral

UID: IMP/MD/2018/000111_dc6c27d84a91622189f8522e723837cd_88c4b47dfaf842c349f31804e78d0d58

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 Annuloplasty Ring is intended for the correction of mitral valve insufficiency or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve