Mechanical Valve
- UID
- IMP/MD/2022/000101_cb6c196a19963abd093b6d79036402ff_8ffff16fdbed5a13671917a6fc1b30f4
- Device class
- Class D
- Brand name
- Carbomedics Prosthetic Heart Valves
- License holder
- Parekh Integrated Services Pvt. Ltd.
- 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
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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