Non-Compliant PTCA Balloon Catheter - India CDSCO Medical Device Registration

Non-Compliant PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000674_ed4fd3ca82a4eadff778a86617f058e1_20eae3d01865da81d72e0b5874ea2a2f. 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

Non-Compliant PTCA Balloon Catheter

UID: IMP/MD/2022/000674_ed4fd3ca82a4eadff778a86617f058e1_20eae3d01865da81d72e0b5874ea2a2f

Brand Name

BioMatrix NeoFlex

License Holder

Biosensors Medical India Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Biosensors RISE NC PTCA Balloon Catheter is indicated for: • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion • post-delivery expansion of balloon expandable coronary stents