Singapore HSA registration DE0506260
JOTEC FlowNit 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
- DE0506260
- Registration Date
- October 06, 2021
- Retention Due Date
- October 05, 2025
Product description
FlowNit Bioseal is indicated in arterial aneurysms and vascular occlusions. FlowNit Bioseal is primarily indicated for vascular replacement in the entire abdominal aorta and 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)
- FlowNit Bioseal Bifurcation FlowNit Bioseal Bifurcation FlowNit Bioseal Bifurcation FlowNit Bioseal Bifurcation FlowNit Bioseal Bifurcation FlowNit Bioseal Bifurcation FlowNit Bioseal Bifurcation FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube FlowNit Bioseal Straight Tube
- Model Identifier(s)
- 35BI1206 35BI1407 35BI1608 35BI1809 35BI2010 35BI2211 35BI2412 35ST0008 35ST0010 35ST1506 35ST1507 35ST1508 35ST1510 35ST1512 35ST1514 35ST1516 35ST1518 35ST1520 35ST1522 35ST1524 35ST3006 35ST3007 35ST3008 35ST3010 35ST3012 35ST3014 35ST3016 35ST3018 35ST3020 35ST3022 35ST3024 35ST6006 35ST6007 35ST6008 35ST6010
About this record
Access comprehensive regulatory information for JOTEC FlowNit 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 DE0506260 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