Aortic Valve - India CDSCO Medical Device Registration

Aortic Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000133_d8eb776597cf043c24a410cafedb15b8_f3e9f234de6c0dc9eba217c11506c3c1. This device is marketed under the brand name MITRIS RESILIA Mitral Valve. 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

Aortic Valve

UID: IMP/MD/2018/000133_d8eb776597cf043c24a410cafedb15b8_f3e9f234de6c0dc9eba217c11506c3c1

Brand Name

MITRIS RESILIA Mitral Valve

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Inspiris Resilia Aortic Valve is intended for use as a heart valve replacement. It is indicated for patients who require replacement of their native or prosthetic aortic valve