31 results · 8ms · Sources: EU EUDAMED, US FDA

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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

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