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Everolimus Eluting Cobalt Chromium Coronary Stent System - India CDSCO Medical Device Registration

Everolimus Eluting Cobalt Chromium Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000430_939a64cca209e686bba520344ef7539d_0981660b56a0034c6f48e359dd34ea80. 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
Everolimus Eluting Cobalt Chromium Coronary Stent System
UID: MFG/MD/2021/000430_939a64cca209e686bba520344ef7539d_0981660b56a0034c6f48e359dd34ea80

Brand Name

ETERNIA, ETERNIA BRIO, ETERNIA SELECT, ETERNIA NEXA

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The Everolimus Eluting Cobalt Chromium Coronary Stent System is indicated for improving luminal diameter and reducing restenosis for the treatment of de novo lesions in native coronary arteries. Everolimus Eluting Cobalt Chromium 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

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