BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    eXero

    Reg #: 3003967489 · FEI: 3003967489 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LODOX SYSTEMS (PTY) LTD.
    Registration Number
    3003967489
    FEI Number
    3003967489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 DARTFIELD RD., KRAMERVILLE
    City
    SANDTON Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K013999

    Owner / Operator

    Firm Name
    LODOX SYSTEMS (PTY) LTD.
    Operator Number
    9048694
    Address
    7 DARTFIELD RD., KRAMERVILLE, --
    City
    SANDTON
    State
    Gauteng
    Postal Code
    1486
    Country
    ZA
    Correspondent
    Hlamalani Makhubela

    US Agent

    Business Name
    Lodox NA, LLC
    Contact Name
    Louis Kulis
    Address
    143 Burton St, Painesville, OH 44077, United States
    City
    Painesville
    State
    OH
    ZIP
    44077
    Country
    US
    Email
    [email protected]
    Phone
    866 6156639 ext. 102

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    eXero Xmplar

    Establishment Types

    Manufacture Medical Device