Biological Heart Valve - India CDSCO Medical Device Registration

Biological Heart Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000373_9abeb6e43375c9e1cc65dbb98be7534a_0557c2cea0b3cb097170dc7cb3e17c2c. This device is marketed under the brand name Perceval PLUS. 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

Biological Heart Valve

UID: IMP/MD/2022/000373_9abeb6e43375c9e1cc65dbb98be7534a_0557c2cea0b3cb097170dc7cb3e17c2c

Brand Name

Perceval PLUS

License Holder

Parekh Integrated Services Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Crown PRT valve is intended for the replacement of malfunctioning native or prosthetic aortic valves. The Crown PRT valve is suggested for use in those patients where long-term anticoagulation therapy may be undesirable for a variety of reasons, such as patients living in remote areas, patients with gastrointestinal or other bleeding problems, patients who may be expected to undergo other surgery, elderly patients and others where difficulty may be expected with anticoagulants, for social, or other medical reasons.