BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CR MD4R FLFS Cassette

    Reg #: 9613151 · FEI: 3003772619 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    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
    K111324

    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
    Full Field Digital, System, X-Ray, Mammographic MUE

    Proprietary Names

    CR MD4R FLFS Cassette CR MD4R General SR Set CR MD4R FLFS Set CR HD5 Extremities Cassette CR MD4R General Plate CR MD4R General SR Plate NX 3 CR HD5 FLFS Detector CR HD5 FLFS Cassette DX-M CR HD5 General Detector CR MD4R General Set CR HD5 AEC Cassette CR MD4R General Cassette CR HD5 AEC Detector CR HD5 General SR Detector CR HD5 Extremities Detector CR MD4R General SR Cassette

    Establishment Types

    Manufacture Medical Device