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/2022/000674_6a11d97158630de4cf3efb410f3c818b_546e5f6135c32af28a6d0e119fb2ad76. This device is marketed under the brand name BioMatrix NeoFlex. The license holder is Biosensors Medical India 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 Eluting Coronary Stent System

UID: IMP/MD/2022/000674_6a11d97158630de4cf3efb410f3c818b_546e5f6135c32af28a6d0e119fb2ad76

Brand Name

BioMatrix NeoFlex

License Holder

Biosensors Medical India Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

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