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_df38b9f6b4bb62bc29c29f6faff5af3b. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class D

Drug Eluting Coronary Stent System

UID: IMP/MD/2022/000674_6a11d97158630de4cf3efb410f3c818b_df38b9f6b4bb62bc29c29f6faff5af3b

Brand Name

BioMatrix NeoFlex

License Holder

Biosensors Medical India Pvt. Ltd.

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