Transcatheter Heart Valve - India CDSCO Medical Device Registration

Transcatheter Heart Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000225_5f313cd4b1aa3cbe296cc3909c330b1a_346d233d5da43b9b04afeaab5b50762b. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class D

Transcatheter Heart Valve

UID: IMP/MD/2019/000225_5f313cd4b1aa3cbe296cc3909c330b1a_346d233d5da43b9b04afeaab5b50762b

Brand Name

Inspiris Resilia Aortic Valve

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Edwards SAPIEN 3 valve, Edwards Commander delivery system and accessories are indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery with age 65 of years or above? and ?for use in patients with symptomatic heart disease due to a failing aortic bioprosthetic valve or a failing mitral surgical bioprothetic valve who are judged by a heart team to be at high or greater risk for open surgical therapy i.e. a predicted risk of surgical mortality ? 8% at 30 days based on the STS risk score and other Clinical co-morbidities unmeasured by the STS risk calculator

Class D

Transcatheter Heart Valve

Brand: MITRIS RESILIA Mitral Valve

Edwards Lifesciences (India) Private Limited,

Class D

Brand: Fem-Flex II™ Femoral Arterial Cannula

Class D