BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Somfit

    Reg #: 9613619 · FEI: 3004674371 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    COMPUMEDICS LIMITED
    Registration Number
    9613619
    FEI Number
    3004674371
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30-40 Flockhart Street,, Abbotsford,
    City
    Melbourne Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K231546

    Owner / Operator

    Firm Name
    Compumedics
    Operator Number
    10027560
    Address
    30-40 Flockhart Street
    City
    Abbotsford
    State
    Victoria
    Postal Code
    3067
    Country
    AU
    Correspondent
    John Joseph

    US Agent

    Business Name
    Compumedics USA Ltd
    Contact Name
    Steve Johnson
    Address
    5015 W W T Harris Blvd Ste E
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US
    Email
    [email protected]
    Phone
    704 7493200 ext. 5

    Products

    Device Name Product Code
    Reduced- Montage Standard Electroencephalograph OMC
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Somfit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device