Biosensors BioMatrix Flex Drug Eluting Coronary Stent System - HSA Registration DE0017318
Access comprehensive regulatory information for Biosensors BioMatrix Flex Drug Eluting Coronary Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0017318 and owned by Biosensors Europe SA. The device was registered on July 14, 2015.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The BioMatrix Flex™ DES is indicated for improving coronary luminal diameter for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 mm. Stents with length 33 mm and 36 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm. The BioMatrix Flex™ DES with stent length up to 28 mm is also indicated for use in patients with: • ST Elevated Myocardial Infarction (STEMI) • Acute Coronary Syndromes (ACS) including ACS-STEMI, ACS-NSTEMI and Unstable Angina • Diabetes Mellitus