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_114116a8b67cc1c20db76cce5aea9242. 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_114116a8b67cc1c20db76cce5aea9242

Brand Name

Carbomedics Prosthetic Heart Valves

License Holder

Parekh Integrated Services Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Bicarbon prosthesis is intended for use as a replacement valve in patients with diseased, damaged, or malfunctioning mitral or aortic heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic heart valve. The Bicarbon Fitline Aortic prosthesis, Slimline Aortic prosthesis, and Overline Aortic prosthesis are indicated for aortic valve replacement. The Bicarbon Fitline Mitral prosthesis is 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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