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Everolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration

Everolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000042_c87d460d00d3564b32bb8aea8cee3662_b978ce579930f784b652ea8714ede06d. This device is marketed under the brand name Explorer. The license holder is Dolphin Lifescience India LLP, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class D
Everolimus Eluting Coronary Stent System
UID: MFG/MD/2019/000042_c87d460d00d3564b32bb8aea8cee3662_b978ce579930f784b652ea8714ede06d

Brand Name

Explorer

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Hestia- Everolimus Eluting Coronary Stent System is indicated for improving myocardial blood flow and luminal diameter in patients with stenotic lesions in coronary arteries but not limited to patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries. Hestia- Everolimus Eluting Coronary Stent System is intended for use in treatment of: Acute coronary syndrome, Unstable angina, Coronary saphenous vein graft lesions, Coronary artery total occlusion lesions , In-stent restenosis in coronary artery lesions

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