BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Philips Allura XPER FD10

    Reg #: 3009963139 · FEI: 3009963139 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KUEHNE GMBH
    Registration Number
    3009963139
    FEI Number
    3009963139
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Beratgerstr. 19
    City
    Dortmund North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K130842

    Owner / Operator

    Firm Name
    Kuehne GmbH
    Operator Number
    10088909
    Address
    Beratgerstr. 19
    City
    Dortmund
    State
    North Rhine-Westphalia
    Postal Code
    44149
    Country
    DE
    Correspondent
    Gerrit Runte

    US Agent

    Business Name
    Block Imaging
    Contact Name
    Mackenzie Dryer
    Address
    1845 Cedar Street
    City
    Holt
    State
    MI
    ZIP
    48842
    Country
    US
    Email
    [email protected]
    Phone
    517 9997099

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI

    Proprietary Names

    Philips Allura XPER FD10

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device