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

Cobalt Chromium Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000053_f4be0cf933dc28b848f34e9dbc5b3150_1422039137077fb584e814ceba841551. This device is marketed under the brand name FlexiTrack SC, FlexiTrack NC. The license holder is Sahajanand Laser Technology Limited (SLTL), 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
Cobalt Chromium Sirolimus Eluting Coronary Stent System
UID: MFG/MD/2021/000053_f4be0cf933dc28b848f34e9dbc5b3150_1422039137077fb584e814ceba841551

Brand Name

FlexiTrack SC, FlexiTrack NC

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

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

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