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Singapore HSA registration DE0018565

Biosensors BioMatrix Alpha Drug Eluting Coronary Stent System

Singapore flagSingapore·CLASS COM·Biosensors Europe SA·Registered September 20, 2016
Device classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0018565
Registration Date
September 20, 2016
Change Notification Approval Date
March 06, 2025
Retention Due Date
September 19, 2025
Product description
The BioMatrix Alpha stent is indicated for improving coronary luminal diameter for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging between 2.25mm and 4.0mm. Stents with lengths 33 and 36mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm.
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 Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System BioMatrix Alpha Drug Eluting Coronary Stent System
Model Identifier(s)
BMX6-2209 BMX6-2214 BMX6-2219 BMX6-2224 BMX6-2229 BMX6-2509 BMX6-2514 BMX6-2519 BMX6-2524 BMX6-2529 BMX6-2533 BMX6-2536 BMX6-2709 BMX6-2714 BMX6-2719 BMX6-2724 BMX6-2729 BMX6-2733 BMX6-2736 BMX6-3009 BMX6-3014 BMX6-3019 BMX6-3024 BMX6-3029 BMX6-3033 BMX6-3036 BMX6-3509 BMX6-3514 BMX6-3519 BMX6-3524 BMX6-3529 BMX6-3533 BMX6-3536 BMX6-4009 BMX6-4014 BMX6-4019 BMX6-4024 BMX6-4029
About this record

Access comprehensive regulatory information for Biosensors BioMatrix Alpha 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 DE0018565 and owned by Biosensors Europe SA. The device was registered on September 20, 2016.

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.

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