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/2019/000225_d8eb776597cf043c24a410cafedb15b8_62afa639c0763d679d3fd49a19c15913. This device is marketed under the brand name Inspiris Resilia Aortic 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/2019/000225_d8eb776597cf043c24a410cafedb15b8_62afa639c0763d679d3fd49a19c15913

Brand Name

Inspiris Resilia Aortic Valve

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The INSPIRIS RESILIA aortic valve, Model 11500A, is intended for use as a heart valve replacement. The INSPIRIS RESILIA aortic valve, Model 11500A, is indicated for patients who require replacement of their native or prosthetic aortic valve