9 results
·
8ms
·
Sources: EU EUDAMED, US FDA
IBL International GmbH
Manufacturer
🇩🇪 Germany·23 Basic UDI-DIs·29 Devices·BSI Group The Netherlands B.V.
Phenylalanine (PKU) neonatal Screening Assay
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·IBL International GmbH·On the market·32 countries
Phenylalanine (PKU) neonatal Screening Assay
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·IBL International GmbH·On the market·32 countries
Phenylalanine (PKU) neonatal Screening Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·IBL International GmbH·1 device
Phenylalanine (PKU) neonatal Screening Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·IBL International GmbH·1 device
CE666920
Certificate
MDD Annex II Section 4·i+Med S.Coop.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE-666290
Certificate
MDD Annex II Section 4·i+Med S.Coop.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE666288
Certificate
MDD Annex II (excluding section 4)·i+Med S.Coop.·BSI Group The Netherlands B.V.·3 Basic UDI-DIs
CE665104
Certificate
IVDD Annex IV (excluding sections 4, 6)·IBL International GmbH·BSI Group The Netherlands B.V.·2 Basic UDI-DIs