BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    KUEHNE GMBH

    Reg #: 3009963139 · FEI: 3009963139 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    KUEHNE GMBH
    Registration Number
    3009963139
    FEI Number
    3009963139
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Beratgerstr. 19
    City
    Dortmund North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K093514

    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, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Angiographic IZI
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Tomographic IZF
    System, Nuclear Magnetic Resonance Imaging LNH
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    GE Discovery NM/ CT 670 Philips Gemini PET/CT GE Optima 660 CT GE Discovery 690 PET/CT Philips Allura XPER FD10 BIPS Parts GE Discovery PET/CT GE Rev EVO CT Siemens 097 MRI gradient coil Siemens Artis Zee Allura Xper FD20/20 GE Innova 2100 IQ GE OPTIMA MR450W

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device