BEUDAMED
    FDA Registration Active 🇫🇷 France

    KBA3D v2

    Reg #: 3015383864 · FEI: 3015383864 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    S.M.A.I.O
    Registration Number
    3015383864
    FEI Number
    3015383864
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Place Berthe Morisot, Parc Technologique
    City
    SAINT-PRIEST Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K223841

    Owner / Operator

    Firm Name
    S.M.A.I.O
    Operator Number
    10077967
    Address
    2 Place Berthe Morisot, Parc Technologique
    City
    SAINT-PRIEST
    State
    Auvergne-Rhone-Alpes
    Postal Code
    69800
    Country
    FR
    Correspondent
    Jean-Charles Roussouly

    US Agent

    Business Name
    DAWA MEDICAL LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th street suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    305 5999373

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    KBA3D v2

    Establishment Types

    Manufacture Medical Device