12 results
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25ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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Abbott Diagnostics Medical Co., Ltd.
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
BLOOD COLLECTION, CAPILLARY TUBES
Device
EU IVDR
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Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·On the market
BUFFERS
Device
EU IVDR
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Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·On the market
Determine
Device
EU IVDD
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Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·On the market
HIV AG/AB COMBI - RT & POC
Device
EU IVDD
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Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·On the market·15 countries
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
Determine HIV Early Detect
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
EDTA Capillary Tubes
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Determine HIV Controls
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Chase Buffer
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
V7 103108 0005
Certificate
IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V7 103108 0007
Certificate
IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI