BEUDAMED
    8 results · 68ms · 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.

    SC1 Handheld Ultrasound Imaging System (Model: SC1)

    FDA registration
    EZONO AG·2 products·🇩🇪 Germany

    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

    EZONO 4000

    FDA 510(k)
    FDA Class 2 ·Radiology

    SC1 Handheld ultrasound imaging system

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·FCU Co., Ltd.·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

    eZono AG

    Importer
    🇩🇪 Germany·2 Manufacturers

    eZono AG

    Authorized representative
    🇩🇪 Germany·1 Manufacturer·1 Device