BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MIE - LFOV SCINTRON

    Reg #: 1423348 · FEI: 3000210013 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MIE AMERICA, INC.
    Registration Number
    1423348
    FEI Number
    3000210013
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    420 BENNETT RD.
    City
    ELK GROVE VILLAGE
    State
    IL
    ZIP
    60007
    Country
    US

    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

    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

    Complaint File Establishment per 21 CFR 820.198