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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 IMP/MD/2019/000188_dd9e936185c45bb38483da5470752fd4_fd59303bd7b79ab8d33ed3e9a31facd7. This device is marketed under the brand name AMICATH II. The license holder is EVENT MEDI SYSTEMS, and it is classified as Device Class Class D. The approving authority is CDSCO.

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
Sirolimus Eluting Coronary Stent System
UID: IMP/MD/2019/000188_dd9e936185c45bb38483da5470752fd4_fd59303bd7b79ab8d33ed3e9a31facd7

Brand Name

AMICATH II

License Holder

EVENT MEDI SYSTEMS

Device Class

Class D

Approving Authority

CDSCO

Product Information

ihtDEStiny Sirolimus Eluting Coronary Stent System, is indicated for use in percutaneous transluminal coronary angioplasty (AMICATH II) for permanent dilation of the stenotic part of a native coronary artery, through the placement of a coronary stent in order to improve myocardial perfusion

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