17 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Nucleix
Manufacturer
🇮🇱 Israel
Sanway Gene Tech. Inc.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
IVD INSTRUMENTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·CITOTEST LABWARE MANUFACTURING CO.,LTD·On the market·20 countries
VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·On the market·3 countries
Recalcifying solution IVD
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Micropoint Biotechnologies Co., Ltd.·1 device
Coagulation analyser IVD, point-of-care
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Micropoint Biotechnologies Co., Ltd.·1 device
Coagulation analyser IVD, point-of-care
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Micropoint Biotechnologies Co., Ltd.·1 device
Coagulation analyser IVD, point-of-care
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Micropoint Biotechnologies Co., Ltd.·1 device
Coagulation analyser IVD, point-of-care
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Micropoint Biotechnologies Co., Ltd.·1 device
Fluorescent immunoassay analyser IVD, point-of-care
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Micropoint Biotechnologies Co., Ltd.·1 device
Fluorescent immunoassay analyser IVD, point-of-care
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Micropoint Biotechnologies Co., Ltd.·1 device
1434-IVDD-198/2022
Certificate
IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
1434-IVDD-199/2022
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·1 device