BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Barco Mammo Tomosynthesis

    Reg #: 9613188 · FEI: 3004455125 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BARCO N.V.
    Registration Number
    9613188
    FEI Number
    3004455125
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    35 PRESIDENT KENNEDYPARK
    City
    KORTRIJK West-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K103792

    Owner / Operator

    Firm Name
    BARCO NV
    Operator Number
    9031117
    Address
    Beneluxpark 21
    City
    Kortrijk
    State
    West-Vlaanderen
    Postal Code
    8500
    Country
    BE

    US Agent

    Business Name
    Barco Inc.
    Contact Name
    Roxana Allen
    Address
    3059 Premiere Parkway,Suite 400
    City
    Duluth
    State
    GA
    ZIP
    30097
    Country
    US
    Email
    [email protected]
    Phone
    678 2008674

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Barco Mammo Tomosynthesis MDMG-5221

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device