Pericardial Bioprosthesis - India CDSCO Medical Device Registration

Pericardial Bioprosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000225_b139746a26dbcd9ee5cf0f9ac7f51844_d66dd4a58483f987f8ac81776d9a5706. 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

Pericardial Bioprosthesis

UID: IMP/MD/2019/000225_b139746a26dbcd9ee5cf0f9ac7f51844_d66dd4a58483f987f8ac81776d9a5706

Brand Name

Inspiris Resilia Aortic Valve

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Carpentier-Edwards PERIMOUNT Magna Mitral Ease pericardial bioprosthesis is indicated for patients who require replacement of their native or prosthetic mitral valve.