BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CR 10-X

    Reg #: 9613152 · FEI: 3003772616 · 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
    9613152
    FEI Number
    3003772616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MAX PLANCK STRASSE 1
    City
    PEISSENBERG Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K121948

    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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    CR 10-X CR MD1 General Set CR MD1 General Cassette CR MD1 General Plate CR Reader

    Establishment Types

    Manufacture Medical Device