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JOTEC FlowNit Bioseal Textile Vascular Graft - HSA Registration DE0506260

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.

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CLASS D
DE0506260
JOTEC FlowNit Bioseal Textile Vascular Graft
HSA Registration Number: DE0506260
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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.

Device 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 Owner
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