Mitral Valve - India CDSCO Medical Device Registration

Mitral Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000133_7fcdb0ba8c7003a997ec26ab4b5248e1_4bc617722f7f9375657e11794d358ef4. 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

Mitral Valve

UID: IMP/MD/2018/000133_7fcdb0ba8c7003a997ec26ab4b5248e1_4bc617722f7f9375657e11794d358ef4

Brand Name

MITRIS RESILIA Mitral Valve

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The MITRIS RESILA Mitral Valve, model 11400M is intended for use as a heart valve replacement. The MITRIS RESILIA Mitral Valve, model 11400M is indicated for the replacement of native or prosthetic mitral heart valves