BEUDAMED
    Basic UDI-DI Eu Mdd Eu Md Class 2a 🇰🇷 South Korea

    SC1 Handheld ultrasound imaging system

    Code: B-08800076600119
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-08800076600119
    Issuing Agency
    EUDAMED
    Device Model
    SC1
    Types
    Active Measuring function
    Regulation
    Eu Mdd Legacy
    Classification
    Eu Md Class 2a
    Manufacturer
    FCU Co., Ltd.
    Last Updated
    September 12, 2024

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) 1434-MDD-365/2021 May 27, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE,ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L On the market