BEUDAMED
    Basic UDI-DI Eu Mdd Eu Md Class 2a 🇺🇸 United States

    Makoto Intravascular Imaging System™

    Code: B-00857595006432
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00857595006432
    Issuing Agency
    EUDAMED
    Device Model
    TVC-MC10/TVC-MC10i
    Types
    Active Measuring function
    Regulation
    Eu Mdd Legacy
    Classification
    Eu Md Class 2a
    Manufacturer
    Infraredx, Inc.
    Last Updated
    April 11, 2024

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) 670602 May 26, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Makoto Intravascular Imaging System™ On the market