Bare Metal Stent - India CDSCO Medical Device Registration

Bare Metal Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000475_dae509905759c56f3f389d6b96a697f6_6a214a49404a4e56caf4b1b5565059f8. This device is marketed under the brand name Sirolimus. The license holder is Newtech Medical Devices Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Sub Zonal Baddi.

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

CDSCO Registered

Class Class D

Bare Metal Stent

UID: MFG/MD/2023/000475_dae509905759c56f3f389d6b96a697f6_6a214a49404a4e56caf4b1b5565059f8

Brand Name

Sirolimus

License Holder

Newtech Medical Devices Pvt. Ltd.

Device Class

Class D

Approving Authority

Sub Zonal Baddi

Product Information

Bare Metal Stent System is indicted for improving coronary luminal diameters in patients including those with diabetes mellitus with symptomatic ischemic heart disease Stable angia unstable angina non- ST elevtion documented due to arthrsclerotic lesion in native coronary arteries