Singapore HSA registration DE0506039
Biosensors BioFreedom Ultra Drug Coated Coronary Stent System
Singapore·CLASS COM·Biosensors Europe SA·Registered August 02, 2021Device classification
- Device Class
- CLASS COM
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0506039
- Registration Date
- August 02, 2021
- Change Notification Approval Date
- December 13, 2024
- Retention Due Date
- August 01, 2025
Product description
The BioFreedom Ultra DCS is indicated for improving coronary luminal diameter for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging from 2.25 mm to 4.0 mm. Stents with lengths of 33 mm and 36 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm.
Product Owner
- Short Name
- Biosensors
- Address
- Rue de Lausanne 29, 1110 Morges, SWITZERLAND
Registrant
- Address
- 36 JALAN TUKANG, SINGAPORE 619266
Importer
- Address
- 36 JALAN TUKANG, SINGAPORE 619266
Model information
- Model Name(s)
- BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra BioFreedom Ultra
- Model Identifier(s)
- BFC1-2209 BFC1-2214 BFC1-2219 BFC1-2224 BFC1-2229 BFC1-2509 BFC1-2514 BFC1-2519 BFC1-2524 BFC1-2529 BFC1-2533 BFC1-2536 BFC1-2709 BFC1-2714 BFC1-2719 BFC1-2724 BFC1-2729 BFC1-2733 BFC1-2736 BFC1-3009 BFC1-3014 BFC1-3019 BFC1-3024 BFC1-3029 BFC1-3033 BFC1-3036 BFC1-3509 BFC1-3514 BFC1-3519 BFC1-3524 BFC1-3529 BFC1-3533 BFC1-3536 BFC1-4009 BFC1-4014 BFC1-4019 BFC1-4024 BFC1-4029
About this record
Access comprehensive regulatory information for Biosensors BioFreedom Ultra 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 DE0506039 and owned by Biosensors Europe SA. The device was registered on August 02, 2021.
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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