14 results
·
11ms
·
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.
Igentify Ltd.
Manufacturer
🇮🇱 Israel
Acro Biotech Inc.
Manufacturer
🇺🇸 United States·3 Importers
Human Xtensions Ltd.
Manufacturer
🇮🇱 Israel·2 Basic UDI-DIs·3 Devices·1 Importer
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
HandX Needle Holder
Device
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·On the market·5 countries
HandX Handpiece
Device
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·On the market·5 countries
HandX Self- righting Needle Holder
Device
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·On the market·5 countries
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
HandX Needle Holder
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·2 devices
HandX Handpiece
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Human Xtensions 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