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Singapore HSA registration DE0017807

Biosensors BioFreedom™ Drug Coated Coronary Stent System

Singapore flagSingapore·CLASS COM·Biosensors Europe SA·Registered January 25, 2016
Device classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0017807
Registration Date
January 25, 2016
Change Notification Approval Date
May 06, 2025
Retention Due Date
January 24, 2026
Product description
The BioFreedom DCS 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 lengths 33 mm, 36 mm, 42 mm and 48 mm 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)
BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System BioFreedom Drug Coated Coronary Stent System
Model Identifier(s)
BFR1-2208 BFR1-2211 BFR1-2214 BFR1-2218 BFR1-2224 BFR1-2228 BFR1-2508 BFR1-2511 BFR1-2514 BFR1-2518 BFR1-2524 BFR1-2528 BFR1-2533 BFR1-2536 BFR1-2542 BFR1-2548 BFR1-2708 BFR1-2711 BFR1-2714 BFR1-2718 BFR1-2724 BFR1-2728 BFR1-2733 BFR1-2736 BFR1-2742 BFR1-2748 BFR1-3008 BFR1-3011 BFR1-3014 BFR1-3018 BFR1-3024 BFR1-3028 BFR1-3033 BFR1-3036 BFR1-3042 BFR1-3048 BFR1-3508 BFR1-3511 BFR1-3514 BFR1-3518 BFR1-3524 BFR1-3528 BFR1-3533 BFR1-3536 BFR1-3542 BFR1-3548 BFR1-4008 BFR1-4011 BFR1-4014 BFR1-4018 BFR1-4024 BFR1-4028
About this record

Access comprehensive regulatory information for Biosensors BioFreedom™ Drug Coated 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 DE0017807 and owned by Biosensors Europe SA. The device was registered on January 25, 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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