31 results
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8ms
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Sources: EU EUDAMED, US FDA
GENSPEED Biotech
Manufacturer
🇦🇹 Austria·1 Basic UDI-DI·1 Device·QMD Services GmbH, QMD Services GmbH, QMD Services GmbH, and QMD Services GmbH
MACHEREY-NAGEL GmbH & Co. KG
Manufacturer
🇩🇪 Germany·9 Basic UDI-DIs·14 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
Vitamin D xPOC
Device
EU IVDR
·
Eu Ivd Class B
·GENSPEED Biotech·On the market·1 country
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)
Device
EU IVDR
·
Eu Ivd Class C
·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·On the market·11 countries
Medi-Test Glucose
Device
EU IVDR
·
Eu Ivd Class B
·MACHEREY-NAGEL GmbH & Co. KG·On the market·9 countries
Medi-Test Glucose BHR
Device
EU IVDR
·
Eu Ivd Class B
·MACHEREY-NAGEL GmbH & Co. KG·Not intended for eu market
Vitamin D xPOC
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·GENSPEED Biotech·1 device
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·1 device
immuClone (2) Anti-E IgM and Galileo
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·5 devices
immuClone (1) Anti-c IgM and Galileo
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·5 devices
immuClone Anti-CDE IgM + IgG and Galileo
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·3 devices
immuClone (1) Anti-K IgM and Galileo
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·3 devices
immuClone (2) Anti-K IgM and Automated
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·2 devices
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
ITDA/00002/0
Certificate
IVDR Technical Documentation·GENSPEED Biotech·QMD Services GmbH·1 Basic UDI-DI
immuClone® Rh-Hr Control IgM and Galileo
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·4 devices
immuClone® Anti-D rapid IgM and Galileo
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·4 devices
immuClone® (2) Anti-C IgM and Galileo
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·5 devices
immuClone® (2) Anti-e IgM and Galileo
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·IMMUCOR Medizinische Diagnostik GmbH·5 devices