Bare Metal Stent System
- UID
- MFG/MD/2019/000227_ccfa10c09d91d088f9a4c52390716890_4bc3deed4b248d60945b2c8fc68f31e9
- Device class
- Class D
- Brand name
- Racer PC
- License holder
- Translumina Therapeutics LLP
- Approving authority
- CDSCO -North Zone, Ghaziabad
- Product information
- Flaxon-Stent System is indicated for intraluminal chronic placement in stenosed coronary artery or aorto-coronary bypass grafts or the tibial anterior and posterior artery of the lower limb with a maximum lesion length of 48 mm, in order to obtain vessel patency following acute or subacute artery obstruction. It is also indicated in restenosis or arterial dissection after PTCA procedures
Bare Metal Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000227_ccfa10c09d91d088f9a4c52390716890_4bc3deed4b248d60945b2c8fc68f31e9. This device is marketed under the brand name Racer PC. The license holder is Translumina Therapeutics LLP, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.
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.