37 results
·
9ms
·
Sources: EU EUDAMED, US FDA
U-AQ Smart
Device
EU IVDR
·
Eu Ivd Class A
·DFI Co.,Ltd.·On the market
TRUELINE R-300
Device
EU IVDR
·
Eu Ivd Class A
·DFI Co.,Ltd.·On the market
CYBOW R-60S
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DFI Co.,Ltd.·3 devices
CYBOW R-50S
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DFI Co.,Ltd.·6 devices
CYBOW R-600S
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DFI Co.,Ltd.·4 devices
CYBOW Reader 300
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DFI Co.,Ltd.·5 devices
EasySep™ Buffer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·STEMCELL Technologies Canada Inc·1 device
EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·STEMCELL Technologies Canada Inc·1 device
EasySep™ Human Bone Marrow CD138 Positive Selection Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·STEMCELL Technologies Canada Inc·1 device
SepMate
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·STEMCELL Technologies Canada Inc·2 devices
HX 2028254-1
Certificate
IVDR QMS·DFI Co.,Ltd.·TÜV Rheinland LGA Products GmbH
35591
Certificate
MDD Annex II (excluding section 4)·Kurin, Inc.·GMED SAS·37 Basic UDI-DIs
0459
Certificate
MDD Annex II (excluding section 4)·Kurin, Inc.·GMED SAS·2 Basic UDI-DIs
35991
Certificate
MDD Annex II (excluding section 4)·Kurin, Inc.·GMED SAS·1 Basic UDI-DI
20560
Certificate
IVDD Annex IV (excluding sections 4, 6)·Biomerica, Inc.·GMED SAS·10 Basic UDI-DIs
29144
Certificate
MDD Annex II (excluding section 4)·Embolx, Inc.·GMED SAS·10 Basic UDI-DIs
36107
Certificate
MDD Annex II (excluding section 4)·Liberate Medical LLC·GMED SAS·1 Basic UDI-DI