Mechanical Valve - India CDSCO Medical Device Registration

Mechanical Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000101_cb6c196a19963abd093b6d79036402ff_8ffff16fdbed5a13671917a6fc1b30f4. This device is marketed under the brand name Carbomedics Prosthetic Heart Valves. The license holder is Parekh Integrated Services Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Mechanical Valve

UID: IMP/MD/2022/000101_cb6c196a19963abd093b6d79036402ff_8ffff16fdbed5a13671917a6fc1b30f4

Brand Name

Carbomedics Prosthetic Heart Valves

License Holder

Parekh Integrated Services Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Carbomedics Prosthetic Heart Valve is intended for use as a replacement valve in patients with diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted aortic or mitral prosthetic heart valve. This device may also be used to replace a previously implanted aortic or mitral prosthetic heart valve. The Carbomedics Standard Aortic Valve, Reduced Aortic Valve, Supra-Annular Aortic Valve (Carbomedics Prosthetic Heart Valves), and Orbis Aortic Valve are indicated for aortic valve replacement. The Carbomedics Standard Mitral Valve, Orbis Mitral Valve, and OptiForm Mitral Valve are indicated for mitral valve replacement

Class D

Ascending Aortic Prosthesis

Brand: Carbomedics Prosthetic Heart Valves

LIVANOVA INDIA PVT. LTD.

Class D

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