6 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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FEMNA Care
Device
EU MDR
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Eu Md Class 1
·FEMNA Health M.E. GmbH·On the market
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·June 5, 2019
FEMNA Care
Basic UDI-DI
EU MDR
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Eu Md Class 1
·FEMNA Health M.E. GmbH·1 device
MTS Medizintechnische Servicegesellschaft mbH
Importer
🇩🇪 Germany·1 Manufacturer
MTS Medizintechnische Servicegesellschaft mbH
System producer
🇩🇪 Germany
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices