18 results
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7ms
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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
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
Vitamin D xPOC
Device
EU IVDR
·
Eu Ivd Class B
·GENSPEED Biotech·On the market·1 country
Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·4 Devices·2 Importers·Sertio Oy
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer
🇨🇳 China·29 Basic UDI-DIs·29 Devices·4 Importers·Sertio Oy, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
QMD Services GmbH
Notified body
🇦🇹 Austria·6 Manufacturers·1 Basic UDI-DI
Vitamin D xPOC
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·GENSPEED Biotech·1 device
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
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
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
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·4 devices
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
EU-TDA-FI-20642-800030-2025-1
Certificate
IVDR Technical Documentation·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·Sertio Oy·1 Basic UDI-DI
EU-TDA-FI-06912-800035-2025-1
Certificate
IVDR Technical Documentation·Jiangsu Medomics Medical Technology Co.,Ltd.·Sertio Oy·1 Basic UDI-DI