8,902 results
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52ms
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Sources: EU EUDAMED, US FDA
KD Medical GmbH Hospital Products
Importer
🇩🇪 Germany
1434-IVDD-198/2022
Certificate
IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
1434-IVDD-199/2022
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·1 device
QMD Services GmbH
Notified body
🇦🇹 Austria·6 Manufacturers·1 Basic UDI-DI
DGM-0549
Certificate
IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI
DGM-459
Certificate
IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·2 Basic UDI-DIs
DGM-458
Certificate
IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI
DGM-549
Certificate
IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·31 Basic UDI-DIs
DGM-548
Certificate
IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·33 Basic UDI-DIs
INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
INSTI COVID ANTIBODY TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV CONTROL TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device