Pure Global

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/2021/000368_dd9e936185c45bb38483da5470752fd4_f466b3956e974bf015ceb3e29c44a73c. This device is marketed under the brand name Endorser, Patron, Hotron, Flextron. The license holder is Veritas Bioventions Pvt. Ltd, 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.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class D
Sirolimus Eluting Coronary Stent System
UID: MFG/MD/2021/000368_dd9e936185c45bb38483da5470752fd4_f466b3956e974bf015ceb3e29c44a73c

Brand Name

Endorser, Patron, Hotron, Flextron

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The Coronary Stent is indicated for selective implantation and for treatment of acute or threatened closure following intervention in the coronary vasculature, including saphenous vein grafts & is intended to improve coronary luminal diameter. The issues of repeated restenosis are always big problem in metallic stent and to overcome this issue Drug eluting Stents (Endorser, Patron, Hotron, Flextron) are use for angioplasty. The Sinew Sirolimus eluting coronary stent system (Endorser, Patron, Hotron, Flextron) is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo coronary artery lesions with a reference vessel. Diameter ranging from 2.00 mm to 4.50 mm and is intended to improve coronary luminal diameter

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing