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JOTEC FlowLine Bipore HEPARIN ePTFE Vascular Graft - HSA Registration DE0506925

Access comprehensive regulatory information for JOTEC FlowLine Bipore HEPARIN ePTFE 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 DE0506925 and owned by JOTEC GmbH. The device was registered on June 02, 2022.

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
DE0506925
JOTEC FlowLine Bipore HEPARIN ePTFE Vascular Graft
HSA Registration Number: DE0506925
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Product Description

The FlowLine Bipore Heparin ePTFE vascular prothesis is indicated for use in arterial reconstructions, primarily of peripheral blood vessels. It can also be used extra-anatomically in femoro-femoral and axillofemoral vascular reconstructions. The standard wall FlowLine Bipore Heparin ePTFE vascular prosthesis is also indicated for use as an arterio-venous shunt prosthesis in haemodialysis patients.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506925
Registration Date
June 02, 2022
Retention Due Date
June 01, 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)
FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft FlowLine Bipore HEPARIN ePTFE Vascular Graft
Model Identifier(s)
15SW4005N 15SW5006N 15SW5006S 15SW5007N 15SW5007S 15SW5008N 15SW5008S 15SW7005N 15SW8006N 15SW8006S 15SW8007N 15SW8007S 15SW8008N 15SW8008S 15TW4005N 15TW4005S 15TW5006N 15TW5006S 15TW5007N 15TW5007S 15TW5008N 15TW5008S 15TW7005N 15TW7005S 15TW8006N 15TW8006S 15TW8007N 15TW8007S 15TW8008N 15TW8008S