Sirolimus Based Bifurcation Stent System - India CDSCO Medical Device Registration

Sirolimus Based Bifurcation Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000228_f27703a59fac83527824a9455e8100d9_0e88d249d7468e39e89301c11b3256a1. This device is marketed under the brand name Nile SIR, Bifur. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Sirolimus Based Bifurcation Stent System

UID: MFG/MD/2020/000228_f27703a59fac83527824a9455e8100d9_0e88d249d7468e39e89301c11b3256a1

Brand Name

Nile SIR, Bifur

License Holder

Envision Scientific Pvt. Ltd.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

It is indicated for improving coronary artery luminal diameter, while simultaneously maintaining side branch access in patients with symptomatic ischemic disease due to discrete de novo lesions (Nile SIR, Bifur) in native coronary arteries involving a major branch with a main branch reference vessel diameter of 2.50 to 3.50 mm and with a side branch reference vessel diameter of 2.00 to 3.00 mm

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Sirolimus Coated PTA Balloon Catheter

Brand: Nile SIR, Bifur

Envision Scientific Pvt. Ltd.

Class C

Brand: Focus np, Abluminus np, Cynosure

Class D