BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    COMPUMEDICS LIMITED

    Reg #: 9613619 · FEI: 3004674371 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    20
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    COMPUMEDICS LIMITED
    Registration Number
    9613619
    FEI Number
    3004674371
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    30-40 Flockhart Street,, Abbotsford,
    City
    Melbourne Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K000865

    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
    Bailey Lewis
    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
    Electrode, Cutaneous GXY
    Full-Montage Standard Electroencephalograph GWQ
    Standard Polysomnograph With Electroencephalograph OLV
    Media, Electroconductive GYB
    Reduced- Montage Standard Electroencephalograph OMC
    Ventilatory Effort Recorder MNR
    Magnetoencephalograph OLY
    Stimulator, Auditory, Evoked Response GWJ
    Stimulator, Photic, Evoked Response GWE
    Stimulator, Electrical, Evoked Response GWF
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Source Localization Software For Electroencephalograph Or Magnetoencephalograph OLX

    Proprietary Names

    QUIK-CAP Compumedics Siesta System Okti 32 Ch Ambulatory EEG System Okti 64 Ch Ambulatory EEG Recorder Only Okti 128 Ch Ambulatory EEG Recorder Only Okti Ethernet Connection Kit Okti 64 Ch Ambulatory EEG System Okti 128 Ch Ambulatory EEG System Okti 32 Ch Ambulatory EEG Recorder Only Quik Gel, EEG Electrodeconductive Gel Falcon HST Somfit D Somfit Compumedics Somte PSG System Orion LifeSpan MEG Neuvo Compumedics Grael System Synamps2/RT Compumedics Somte System CURRY Multimodal Neuroimaging Software

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device