BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    DR 800

    Reg #: 3001556265 · FEI: 3001556265 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    2

    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

    Regulatory Submissions

    510(k) Number
    K183275

    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
    System, X-Ray, Tomographic IZF
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    DR 800 NX 4 Pixium FL4343 NX 3 DR 800 FLFS Overlay Wallstand WS-Manual-T-001 Wallstand WS-Manual-001

    Establishment Types

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