24 results
·
8ms
·
Sources: EU EUDAMED, US FDA
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
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
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
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
Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·4 Devices·2 Importers·Sertio Oy
IX 1038121-3
Certificate
IVDR Technical Documentation·MACHEREY-NAGEL GmbH & Co. KG·TÜV Rheinland LGA Products GmbH
IX1038121-3
Certificate
IVDR Technical Documentation·MACHEREY-NAGEL GmbH & Co. KG·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
Medi-Test Glucose
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·MACHEREY-NAGEL GmbH & Co. KG·2 devices
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Device
EU IVDR
·
Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Device
EU IVDR
·
Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries