BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    USCOM LIMITED

    Reg #: 3004987887 · FEI: 3004987887 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    USCOM LIMITED
    Registration Number
    3004987887
    FEI Number
    3004987887
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LEVEL 8, 66 CLARENCE STREET
    City
    SYDNEY New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K121266

    Owner / Operator

    Firm Name
    USCOM LIMITED
    Operator Number
    9068236
    Address
    LEVEL 8, 66 CLARENCE STREET, --
    City
    SYDNEY, NSW
    State
    New South Wales
    Postal Code
    2000
    Country
    AU
    Correspondent
    NICK - SCHICHT

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Transducer, Ultrasonic, Diagnostic ITX
    Plethysmograph, Impedance DSB
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    BP+ USCOM 1A

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device