12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Austria
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GENSPEED Biotech
Manufacturer
🇦🇹 Austria·1 Basic UDI-DI·1 Device·QMD Services GmbH, QMD Services GmbH, QMD Services GmbH, and QMD Services GmbH
MacroArray Diagnostics
Manufacturer
🇦🇹 Austria·11 Basic UDI-DIs·13 Devices·QMD Services GmbH
Vitamin D xPOC
Device
EU IVDR
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Eu Ivd Class B
·GENSPEED Biotech·On the market·1 country
edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK
FDA 510(k)
FDA Class 2
·Dental
Vitamin D xPOC
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·GENSPEED Biotech·1 device
Bio-Rad Laboratories Ges.m.b.H
Importer
🇦🇹 Austria·5 Manufacturers
IQMS/00003/0 v002
Certificate
IVDR QMS·MacroArray Diagnostics·QMD Services GmbH
ITDA/00002/0 v002
Certificate
IVDR Technical Documentation·GENSPEED Biotech·QMD Services GmbH
ITDA/00002/0 v001
Certificate
IVDR Technical Documentation·GENSPEED Biotech·QMD Services GmbH
IQMS/00002/0v001
Certificate
IVDR QMS·GENSPEED Biotech·QMD Services GmbH
ITDA/00002/0
Certificate
IVDR Technical Documentation·GENSPEED Biotech·QMD Services GmbH·1 Basic UDI-DI
QMD Services GmbH
Notified body
🇦🇹 Austria·6 Manufacturers·1 Basic UDI-DI