BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    G Plus

    Reg #: 3001556265 · FEI: 3001556265 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    34
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    AGFA N.V.
    Registration Number
    3001556265
    FEI Number
    3001556265
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Septestraat 27
    City
    Mortsel Antwerpen
    Country
    BE

    Owner / Operator

    Firm Name
    Agfa N.V.
    Operator Number
    10058267
    Address
    Septestraat 27
    City
    Mortsel
    State
    BE-NOTA
    Postal Code
    B-2640
    Country
    BE
    Correspondent
    Koen Vervoort

    US Agent

    Business Name
    Agfa US Corp
    Contact Name
    ShaeAnn Cavanagh
    Address
    580 Gotham Parkway
    City
    Carlstadt
    State
    NJ
    ZIP
    07072
    Country
    US
    Email
    [email protected]
    Phone
    864 3135016

    Products

    Device Name Product Code
    Film, Radiographic IWZ

    Proprietary Names

    G Plus Mamoray HT Dentus MZ Ortho CP-GU Drystar DT2 Mammo Medlink G 1 Ortho CP-GU M B Plus - Full Blue SG - Regular Green Mamoray HDR Dentus E-Speed Medlink B 1 DirectVista 002-003-004.3 Codonics Dry B SP Crystal Film CF-M CP-BU New DirectVista 002-001-004.3 Codonics Dry Mamoray HDR-C M Plus - Half Blue Ortho CP-G Plus Drystar Mammo Codonics Dry B LS Codonics Dry C Crystal Film CF-B Dental M2 Comfort CP-BU M Mamoray HDR-C Plus Drystar DT2C Dentus Ortholux Register Drystar DT2B Dentus Ortholux Pet Plates Coated Film

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198