13 results
·
9ms
·
Sources: EU EUDAMED, US FDA
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
IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device
EU MDD
·
Eu Md Class 2b
·AST VisionCare Inc.·On the market·10 countries
Inion FreedomPin™
Device
EU MDD
·
Eu Md Class 3
·Inion Oy·On the market·32 countries
IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device
EU MDD
·
Eu Md Class 2b
·AST VisionCare Inc.·On the market·10 countries
IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device
EU MDD
·
Eu Md Class 2b
·AST VisionCare Inc.·On the market·10 countries
Softec HD™ Click
Device
EU MDD
·
Eu Md Class 2b
·Lenstec (Barbados) Inc.·On the market·1 country
PTA BALLOON DILATATION CATHETERS
Device
EU MDD
·
Eu Md Class 2a
·BrosMed Medical Co., Ltd·On the market·1 country
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
Asqelio Trifocal Soft Hydrophobic Intraocular Lens
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AST VisionCare Inc.·1 device
Inion FreedomPin
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·Inion Oy·1 device
CE665104
Certificate
IVDD Annex IV (excluding sections 4, 6)·IBL International GmbH·BSI Group The Netherlands B.V.·2 Basic UDI-DIs