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/2019/000235_6a11d97158630de4cf3efb410f3c818b_fc677641361dae7781c4d17fe2c95c75. This device is marketed under the brand name BioFreedom. The license holder is EURASIA HEALTHCARE LLP, 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/2019/000235_6a11d97158630de4cf3efb410f3c818b_fc677641361dae7781c4d17fe2c95c75

Brand Name

BioFreedom

License Holder

EURASIA HEALTHCARE LLP

Device Class

Class D

Approving Authority

CDSCO

Product Information

The BioMatrix Flex DES 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 length 33mm and 36mm are only available for artery diameters ranging between 2.5mm and 3.5mm. The BioMatrix Flex DES with stent length up to 28 mm is also indicated for use in patients with: • ST elevated myocardial infarction (BioFreedom) • Acute Coronary Syndromes (BioFreedom) including ACS-STEMI, ACS-NSTEMI and Unstable Angina • Diabetes Mellitus