4 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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HYDRASYS 1 IF / 1 BENCE JONES ACCESSORIES (SM)
Device
EU IVDR
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Eu Ivd Class A
·sebia·On the market
HYDRASYS 2 IF / BJ (HR) ACCESSORIES (SM)
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·sebia·1 device
HYDRASYS 1 IF / 1 BENCE JONES ACCESSORIES (SM)
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·sebia·1 device
TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
FDA Enforcement
Class III
·Terminated·Technidata S.A.·April 9, 2014