BEUDAMED
    FDA Registration Active 🇫🇷 France

    GLEAMER

    Reg #: 3021907554 · FEI: 3021907554 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GLEAMER
    Registration Number
    3021907554
    FEI Number
    3021907554
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    47bis Rue des Vinaigriers
    City
    Paris Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K241593

    Owner / Operator

    Firm Name
    GLEAMER
    Operator Number
    10084623
    Address
    47bis Rue des Vinaigriers
    City
    Paris
    State
    Ile-de-France
    Postal Code
    75010
    Country
    FR
    Correspondent
    Antoine Tournier

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    Radiological Computer Assisted Detection/Diagnosis Software For Fracture QBS
    Analyzer, Medical Image MYN

    Proprietary Names

    BoneMetrics US BoneView ChestView US

    Establishment Types

    Manufacture Medical Device