BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Mamoray Cassette

    Reg #: 9613151 · FEI: 3003772619 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AGFA-GEVAERT HEALTHCARE GMBH
    Registration Number
    9613151
    FEI Number
    3003772619
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BURGERMEISTER-GOTZ STRASSE 10
    City
    SCHROBENHAUSEN Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K023020

    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
    Cassette, Radiographic Film IXA

    Proprietary Names

    Mamoray Cassette Green 400 Green 100 Blue 800 CAWO ABS Cassette

    Establishment Types

    Manufacture Medical Device