BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    BreastBoard SX

    Reg #: 3010701021 · FEI: 3010701021 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MACROMEDICS BV
    Registration Number
    3010701021
    FEI Number
    3010701021
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oostbaan 670
    City
    Moordrecht Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K213439

    Owner / Operator

    Firm Name
    MacroMedics BV
    Operator Number
    10046168
    Address
    Oostbaan 670
    City
    Moordrecht
    State
    Zuid-Holland
    Postal Code
    2841ML
    Country
    NL
    Correspondent
    J. Drenth

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    Accelerator, Linear, Medical IYE

    Proprietary Names

    BreastBoard SX FlexBoard EagleBoard

    Establishment Types

    Manufacture Medical Device