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/2021/000430_dd9e936185c45bb38483da5470752fd4_cab4e672dfe4da1f27dbe323c2a70007. This device is marketed under the brand name ETERNIA, ETERNIA BRIO, ETERNIA SELECT, ETERNIA NEXA. The license holder is Relisys Medical Devices Limited, and it is classified as Device Class Class D. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered

Class Class D

Sirolimus Eluting Coronary Stent System

UID: MFG/MD/2021/000430_dd9e936185c45bb38483da5470752fd4_cab4e672dfe4da1f27dbe323c2a70007

Brand Name

ETERNIA, ETERNIA BRIO, ETERNIA SELECT, ETERNIA NEXA

License Holder

Relisys Medical Devices Limited

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The Sirolimus Eluting Coronary Stent System is indicated for improving luminal diameter and reducing restenosis for the treatment of de novo lesions in native coronary arteries. Sirolimus Eluting Coronary Stent System is also indicated for treatment of abrupt of threatened closure in patients with failed interventional therapy. The drug coating is intended to inhibit restenosis.