BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Rover

    Reg #: 3012855798 · FEI: 3012855798 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MICRO-X LTD
    Registration Number
    3012855798
    FEI Number
    3012855798
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    A14 6 MAB Eastern Promenade
    City
    Tonsley South Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K201488

    Owner / Operator

    Firm Name
    MICRO-X LTD
    Operator Number
    10057299
    Address
    A14 -6 MAB Eastern Promenade
    City
    Tonsley
    State
    South Australia
    Postal Code
    5042
    Country
    AU
    Correspondent
    Dijana Jerkovic

    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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Mobile IZL

    Proprietary Names

    Rover

    Establishment Types

    Manufacture Medical Device