128 results
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28ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
FDA Enforcement
Class II
·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
FDA Enforcement
Class II
·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
FDA Enforcement
Class II
·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022
IOL expert GmbH & Co. KG
Importer
🇩🇪 Germany·1 Manufacturer
Polytech Domilens GmbH
Importer
🇩🇪 Germany·13 Manufacturers
IBL International GmbH
Manufacturer
🇩🇪 Germany·23 Basic UDI-DIs·29 Devices·BSI Group The Netherlands B.V.
EPMap System GmbH i.L.
Manufacturer
🇩🇪 Germany
IBL INTERNATIONAL GMBH
FDA registration
IBL INTERNATIONAL GMBH·12 products·🇩🇪 Germany
ILO ELECTRONIC GMBH
FDA registration
ILO ELECTRONIC GMBH·4 products·🇩🇪 Germany
dsDNA-Ab RIA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
17beta-Estradiol Saliva Luminescence Immunoassay
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
17beta-Estradiol Saliva Luminescence Immunoassay
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Acetylcholine Receptor Autoantibodies (ARAb) RRA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Progesterone Saliva ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
DHEA ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
25-OH-Vitamin D ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Acetylcholine Receptor Autoantibodies (ARAb) RRA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Acetylcholine Receptor Autoantibodies (ARAb) RRA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries