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Singapore HSA registration DE0504019

JOTEC FlowLine Bipore ePTFE Vascular Graft

Singapore flagSingapore·CLASS D·JOTEC GmbH·Registered January 13, 2020
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0504019
Registration Date
January 13, 2020
Retention Due Date
January 12, 2026
Product description
The FlowLine Bipore ePTFE vascular graft is indicated in cases of arterial reconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstructions – femorofemoral and axillofemoral. Standardwall FlowLine Bipore prosthesis are also indicated for use as arteriovenous shunt prosthesis in haemodialysis.
Product Owner
Name
JOTEC GmbH
Short Name
JOTEC GmbH
Address
Lotzenacker 23, 72379 Hechingen, GERMANY
Registrant
Name
Cryolife Asia Pacific Pte Ltd
Address
1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989
Importer
Name
ALCARE PHARMACEUTICALS PTE LTD
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Model information
Model Name(s)
FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft FlowLine Bipore ePTFE Vascular Graft
Model Identifier(s)
10SW2006N 10SW2007N 10SW4005N 10SW5006N 10SW5006S 10SW5007N 10SW5007S 10SW5008N 10SW5008S 10SW7005N 10SW8006N 10SW8006S 10SW8007N 10SW8007S 10SW8008N 10SW8008S 10TW1005N 10TW1005S 10TW2006N 10TW2007N 10TW2008N 10TW4005N 10TW4005S 10TW5006N 10TW5006S 10TW5007N 10TW5007S 10TW5008N 10TW5008S 10TW7005N 10TW7005S 10TW8006N 10TW8006S 10TW8007N 10TW8007S 10TW8008N 10TW8008S
About this record

Access comprehensive regulatory information for JOTEC FlowLine Bipore 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 DE0504019 and owned by JOTEC GmbH. The device was registered on January 13, 2020.

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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