Singapore HSA registration DE0506259
JOTEC FlowWeave Bioseal Textile Vascular Graft
Singapore·CLASS D·JOTEC GmbH·Registered October 06, 2021Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0506259
- Registration Date
- October 06, 2021
- Retention Due Date
- October 05, 2025
Product description
FlowWeave Bioseal is indicated in arterial aneurysms and vascular occlusions. The primary indication for FlowWeave Bioseal is vascular replacement in the thoracic and abdominal aortas, although it can also be used in peripheral vascular applications involving vessel diameters of at least 6mm.
Product Owner
- Name
- JOTEC GmbH
- Short Name
- JOTEC GmbH
- Address
- Lotzenacker 23, 72379 Hechingen, GERMANY
Registrant
- Address
- 1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989
Importer
- Address
- 12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Model information
- Model Name(s)
- FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube FlowWeave Bioseal Straight Tube
- Model Identifier(s)
- 45ST1508 45ST1510 45ST1512 45ST1520 45ST1522 45ST1524 45ST1526 45ST1528 45ST1530 45ST1532 45ST1534 45ST3008 45ST3010 45ST3012 45ST3020 45ST3022 45ST3024 45ST3026 45ST3028 45ST3030 45ST3032 45ST3034
About this record
Access comprehensive regulatory information for JOTEC FlowWeave Bioseal Textile Vascular Graft in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506259 and owned by JOTEC GmbH. The device was registered on October 06, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D