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JOTEC FlowWeave Bioseal Textile Vascular Graft - HSA Registration DE0506259

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.

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CLASS D
DE0506259
JOTEC FlowWeave Bioseal Textile Vascular Graft
HSA Registration Number: DE0506259
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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.

Device 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 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)
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