7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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FLUOROCELL PLT
Device
EU IVDR
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Eu Ivd Class A
·SYSMEX CORPORATION·On the market·32 countries
FLUOROCELL PLT
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·SYSMEX CORPORATION·1 device
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Sysmex Corporation·June 22, 2016
Lactate Pro 2 (LT-1730)
Device
EU IVDD
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Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 (LT-1730)
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 (LT-1730)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·1 device
Lactate Pro 2 (LT-1730)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·1 device