4 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Denmark
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SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
1ML ONCE Luer Centric Clear Non-sterile
Basic UDI-DI
EU MDR
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Eu Md Class 1
·CODAN Medical ApS·1 device
1 ML CODAN PRIMO TBC Luer Centrisk Clear Sterile
Basic UDI-DI
EU MDR
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Eu Md Class 1
·CODAN Medical ApS·85 devices
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
FDA Enforcement
Class II
·Ongoing·Radiometer Medical ApS·May 25, 2022