BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    OT 3000

    Reg #: 9680497 · FEI: 3008794078 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AGFA HEALTHCARE INC.
    Registration Number
    9680497
    FEI Number
    3008794078
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    375 Hagey Boulevard
    City
    WATERLOO Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K040344

    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
    Template HWT
    System, Image Processing, Radiological LLZ

    Proprietary Names

    OT 3000 Impax Orthopaedic Workstation

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility