10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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MX Healthcare GmbH
Manufacturer
🇩🇪 Germany·3 Basic UDI-DIs·3 Devices
Vara PACS
Device
EU MDR
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Eu Md Class 1
·MX Healthcare GmbH·Not intended for eu market
Vara MG
Device
EU MDR
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Eu Md Class 2b
·MX Healthcare GmbH·On the market·1 country
Vara Flux
Device
EU MDR
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Eu Md Class 1
·MX Healthcare GmbH·Not intended for eu market
immunoLINE IgG4 MX1
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
immunoLINE IgG4 MX2
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
Vara PACS
Basic UDI-DI
EU MDR
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Eu Md Class 1
·MX Healthcare GmbH·1 device
Vara Flux
Basic UDI-DI
EU MDR
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Eu Md Class 1
·MX Healthcare GmbH·1 device
Vara MG
Basic UDI-DI
EU MDR
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Eu Md Class 2b
·MX Healthcare GmbH·1 device
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024