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Transcatheter Aortic Valve - India CDSCO Medical Device Registration

Transcatheter Aortic Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000025_48fe5c68e995038f500d4fd410b1353a_2c437b15ca39acb13dea0a2c8b7b872d. This device is marketed under the brand name Hydra Aortic Valve and Delivery System. The license holder is Vascular Concepts 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.

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CDSCO Registered
Class Class D
Transcatheter Aortic Valve
UID: IMP/MD/2020/000025_48fe5c68e995038f500d4fd410b1353a_2c437b15ca39acb13dea0a2c8b7b872d

Brand Name

Hydra Aortic Valve and Delivery System

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Hydra Valve System is designed for use in high surgical risk patients with severe aortic stenosis. The Hydra Valve System is indicated for patients with severe symptomatic native aortic valve stenosis necessitating valve replacement of the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve and presenting with femoral or subclavian/axillary access vessels with diameters ≥6mm and anatomical dimensions of the aortic annulus diameter between 18mm to 27mm.

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Transcatheter Aortic Valve

Brand: Hydra Aortic Valve and Delivery System along with Components/ Accessories Hydra Aortic Valve, Hydra Aortic Valve Delivery Catheter, Hydra Aortic Valve Loading System

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