BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Nurochek

    Reg #: 3018238599 · FEI: 3018238599 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HEADSAFE MFG PTY LTD
    Registration Number
    3018238599
    FEI Number
    3018238599
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    61 Marlborough St, Suite 76
    City
    Surry Hills New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K200705

    Owner / Operator

    Firm Name
    Headsafe MFG Pty Ltd
    Operator Number
    10081128
    Address
    231 Birrell St
    City
    Bronte
    State
    New South Wales
    Postal Code
    2024
    Country
    AU
    Correspondent
    Adrian Cohen

    US Agent

    Business Name
    RQM+
    Contact Name
    Allison Komiyama
    Address
    2251 San Diego Avenue, Suite B-257
    City
    San Diego
    State
    CA
    ZIP
    92110
    Country
    US
    Email
    [email protected]
    Phone
    412 8168253

    Products

    Device Name Product Code
    Reduced- Montage Standard Electroencephalograph OMC
    Stimulator, Photic, Evoked Response GWE

    Proprietary Names

    Nurochek

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device