10,000 results
·
47ms
·
Sources: EU EUDAMED, US FDA
HIV Self Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atomo Diagnostics Limited·1 device
AmoyDx® FFPE DNA/RNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
KDHT
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·1 device
EDPO
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·11 devices
EKa(p)DH
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·2 devices
Optoacoustic Imaging System
FDA Pre-Market Approval
FDA Class 3
·Imagio® Breast Imaging system
Optoacoustic Imaging System
FDA Pre-Market Approval
FDA Class 3
·Imagio Breast Imaging System
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
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