7 results
·
9ms
·
Sources: EU EUDAMED, US FDA
FCU Co., Ltd.
Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE,ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L
Device
EU MDD
·
Eu Md Class 2a
·FCU Co., Ltd.·On the market·1 country
PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
Device
EU MDD
·
Eu Md Class 2b
·OR-CZ spol. s r.o.·On the market·1 country
SC1 Handheld ultrasound imaging system
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·FCU Co., Ltd.·1 device
MARIE PACS
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·OR-CZ spol. s r.o.·1 device
1434-MDD-365/2021
Certificate
MDD Annex II (excluding section 4)·FCU Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
2021-MDD/QS-022
Certificate
MDD Annex II (excluding section 4)·OR-CZ spol. s r.o.·3EC International a.s.·1 Basic UDI-DI