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Singapore HSA registration DE0017742

Biosensors BioMatrix NeoFlex Drug Eluting Coronary Stent System

Singapore flagSingapore·CLASS COM·Biosensors Europe SA·Registered December 24, 2015
Device classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0017742
Registration Date
December 24, 2015
Change Notification Approval Date
December 13, 2024
Retention Due Date
December 23, 2025
Product description
The BioMatrix NeoFlex 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, 36 mm, 42 mm, and 48 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm. The BioMatrix NeoFlex 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 NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System BioMatrix NeoFlex Drug Eluting Coronary Stent System
Model Identifier(s)
BMXP-2208 BMXP-2211 BMXP-2214 BMXP-2218 BMXP-2224 BMXP-2228 BMXP-2508 BMXP-2511 BMXP-2514 BMXP-2518 BMXP-2524 BMXP-2528 BMXP-2533 BMXP-2536 BMXP-2542 BMXP-2548 BMXP-2708 BMXP-2711 BMXP-2714 BMXP-2718 BMXP-2724 BMXP-2728 BMXP-2733 BMXP-2736 BMXP-2742 BMXP-2748 BMXP-3008 BMXP-3011 BMXP-3014 BMXP-3018 BMXP-3024 BMXP-3028 BMXP-3033 BMXP-3036 BMXP-3042 BMXP-3048 BMXP-3508 BMXP-3511 BMXP-3514 BMXP-3518 BMXP-3524 BMXP-3528 BMXP-3533 BMXP-3536 BMXP-3542 BMXP-3548 BMXP-4008 BMXP-4011 BMXP-4014 BMXP-4018 BMXP-4024 BMXP-4028
About this record

Access comprehensive regulatory information for Biosensors BioMatrix NeoFlex 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 DE0017742 and owned by Biosensors Europe SA. The device was registered on December 24, 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.

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