Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration

Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000143_dd9e936185c45bb38483da5470752fd4_0501fc43f528ede982861d455119ad87. This device is marketed under the brand name Reivas. The license holder is Relisys Medical Devices Limited, and it is classified as Device Class Class C. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered

Class Class C

Sirolimus Eluting Coronary Stent System

UID: MFG/MD/2019/000143_dd9e936185c45bb38483da5470752fd4_0501fc43f528ede982861d455119ad87

Brand Name

Reivas

License Holder

Relisys Medical Devices Limited

Device Class

Class C

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The Sirolimus Eluting Coronary Stent system stent is indicated for improving luminal diameter and reducing restenosis for the treatment of “de novo” lesions in native coronary arteries. It is also indicated for treatment of abrupt or threatened closure in patients with failed interventional therapy. The treated lesions length should be less than the nominal stent length (Reivas) with reference vessel diameters ≥ 2.25 or ≤ 4.00mm