Drug Coated Coronary Stent System - India CDSCO Medical Device Registration

Drug Coated Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000073_d3f48960dfa9a210fb2a16c83b1a0c88_91e1f0a562a1a7c2dbf46cc128d4b017. This device is marketed under the brand name BioFreedom. The license holder is Dr. Remedies Life Sciences 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

Drug Coated Coronary Stent System

UID: IMP/MD/2021/000073_d3f48960dfa9a210fb2a16c83b1a0c88_91e1f0a562a1a7c2dbf46cc128d4b017

Brand Name

BioFreedom

License Holder

Dr. Remedies Life Sciences Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The BioFreedom DCS is indicated for improving coronary luminal diameter for the treatment of de-novo lesions in native coronary arteries with a reference diameter ranging from 2.25 mm to 4.0 mm. Stents with lengths of 33 mm, 36 mm, 42mm & 48mm are only available for artery diameters ranging from 2.5 mm to 3.5 mm

Class D

Drug Eluting Coronary Stent System

Brand: BioFreedom

Dr. Remedies Life Sciences Pvt. Ltd.

Class D

Other Products from Dr. Remedies Life Sciences Pvt. Ltd.

Products from the same license holder (2 products)

Drug Eluting Coronary Stent System

Brand: BioFreedom

Class D

Drug Eluting Coronary Stent System

Brand: BioFreedom

Class D