10 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Prevade™
Device
EU MDD
·
Eu Md Class 3
·Meril Life Sciences Pvt. Ltd.·On the market·1 country
Nova
Device
EU MDR
·
Eu Md Class 1
·Vision Rx Lab Private Limited·On the market·4 countries
Mozec™ PTA 0.035" OTW
Device
EU MDD
·
Eu Md Class 2a
·Meril Life Sciences Pvt. Ltd.·On the market·11 countries
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.
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
Prevade™ Sirolimus Eluting Coronary Stent System
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·Meril Life Sciences Pvt. 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