Drug Eluting Coronary Stent System - India CDSCO Medical Device Registration

Drug Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000510_9469389319889158bcd3080253fe2e04_7f221fabc072e3184b726803d7943b83. This device is marketed under the brand name BioFreedom. The license holder is Cardiologix, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Drug Eluting Coronary Stent System

UID: IMP/MD/2023/000510_9469389319889158bcd3080253fe2e04_7f221fabc072e3184b726803d7943b83

Brand Name

BioFreedom

License Holder

Cardiologix

Device Class

Class D

Approving Authority

CDSCO

Product Information

The BioMatrix Alpha stent is indicated for improving coronary luminal diameter for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 mm. Stents with lengths 33 and 36 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm.