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/2022/000674_d3f48960dfa9a210fb2a16c83b1a0c88_aef6cfef441312cfdf2beadf1b08e133. 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 Coated Coronary Stent System

UID: IMP/MD/2022/000674_d3f48960dfa9a210fb2a16c83b1a0c88_aef6cfef441312cfdf2beadf1b08e133

Brand Name

BioMatrix NeoFlex

License Holder

Biosensors Medical India Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The BioFreedom Ultra 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 and 36 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm.

Class D

Other Products from Biosensors Medical India Pvt. Ltd.

Products from the same license holder (4 products)

Non-Compliant PTCA Balloon Catheter

Brand: BioMatrix NeoFlex

Class D

Drug Coated Coronary Stent System

Brand: BioMatrix NeoFlex

Class D

Drug Eluting Coronary Stent System

Brand: BioMatrix NeoFlex

Class D

Drug Eluting Coronary Stent System

Brand: BioMatrix NeoFlex

Class D