BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    BioXmark

    Reg #: 9614559 · FEI: 3002806942 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EUROPEAN MEDICAL CONTRACT MFG.
    Registration Number
    9614559
    FEI Number
    3002806942
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MIDDENKAMPWEG 17
    City
    NIJMEGEN Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    DEN220017

    Owner / Operator

    Firm Name
    European Medical Contract Manufacturing (E.M.C.M.) B.V.
    Operator Number
    9039600
    Address
    MIDDENKAMPWEG 17, --
    City
    NIJMEGEN
    State
    Gelderland
    Postal Code
    CH 6545
    Country
    NL
    Correspondent
    Mark - Saris

    US Agent

    Business Name
    Kelaveshi
    Contact Name
    Kela Veshi
    Address
    11403 Empire ln
    City
    Rockville
    State
    MD
    ZIP
    20852
    Country
    US
    Email
    [email protected]
    Phone
    301 7920964

    Products

    Device Name Product Code
    Phase-Changing Fiducial Marker For Radiation Therapy QUV

    Proprietary Names

    BioXmark

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)