BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Enterprise Imaging Desktops

    Reg #: 3009238175 · FEI: 3009238175 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Agfa HealthCare
    Registration Number
    3009238175
    FEI Number
    3009238175
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Moutstraat 100
    City
    Gent West-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K142316

    Owner / Operator

    Firm Name
    AGFA HEALTHCARE N.V.
    Operator Number
    9011611
    Address
    375 Hagey Blvd
    City
    Waterloo
    State
    Ontario
    Postal Code
    N2L 6R5
    Country
    CA

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Enterprise Imaging Desktops

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility