BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MIE - LFOV SCINTRON

    Reg #: 3005128583 · FEI: 3005128583 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    MIE GMBH
    Registration Number
    3005128583
    FEI Number
    3005128583
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HAUPTSTR. 112
    City
    SETH Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K053086

    Owner / Operator

    Firm Name
    MIE GMBH
    Operator Number
    9028781
    Address
    Hauptstrasse 112, --
    City
    Seth
    State
    DE-NOTA
    Postal Code
    23845
    Country
    DE
    Correspondent
    Thomas - Kuehl

    US Agent

    Business Name
    MiE America Inc.
    Contact Name
    Dariusz Sury
    Address
    420 Bennett Road
    City
    Elk Grove Village
    State
    IL
    ZIP
    60007
    Country
    US
    Email
    [email protected]
    Phone
    1 8479816 ext. 100

    Products

    Device Name Product Code
    Camera, Scintillation (Gamma) IYX
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    MIE - LFOV SCINTRON MIE - DIACAM SCINTRON MIE - ORBITER SCINTRON MIE - SD-X 37 SCINTRON

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device