Pure Global
Singapore HSA registration DE0017318

Biosensors BioMatrix Flex Drug Eluting Coronary Stent System

Singapore flagSingapore·CLASS COM·Biosensors Europe SA·Registered July 14, 2015
Device classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00107
HS Code
90219000
Registration information
Registration Number
DE0017318
Registration Date
July 14, 2015
Change Notification Approval Date
May 06, 2025
Retention Due Date
July 13, 2025
Product description
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
Product Owner
Name
Biosensors Europe SA
Short Name
Biosensors
Address
Rue de Lausanne 29, 1110 Morges, SWITZERLAND
Registrant
Name
BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD.
Address
36 JALAN TUKANG, SINGAPORE 619266
Importer
Name
BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD.
Address
36 JALAN TUKANG, SINGAPORE 619266
Model information
Model Name(s)
BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System BioMatrix Flex Drug Eluting Coronary Stent System
Model Identifier(s)
BMX-2208 BMX-2211 BMX-2214 BMX-2218 BMX-2224 BMX-2228 BMX-2508 BMX-2511 BMX-2514 BMX-2518 BMX-2524 BMX-2528 BMX-2533 BMX-2536 BMX-2708 BMX-2711 BMX-2714 BMX-2718 BMX-2724 BMX-2728 BMX-2733 BMX-2736 BMX-3008 BMX-3011 BMX-3014 BMX-3018 BMX-3024 BMX-3028 BMX-3033 BMX-3036 BMX-3508 BMX-3511 BMX-3514 BMX-3518 BMX-3524 BMX-3528 BMX-3533 BMX-3536 BMX-4008 BMX-4011 BMX-4014 BMX-4018 BMX-4024 BMX-4028
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS COM