BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    HEADSAFE MFG PTY LTD

    Reg #: 3018238599 · FEI: 3018238599 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HEADSAFE MFG PTY LTD
    Registration Number
    3018238599
    FEI Number
    3018238599
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    61 Marlborough St, Suite 76
    City
    Surry Hills New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K243426

    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

    US Agent

    Business Name
    RQM+
    Contact Name
    Jonathan Gimbel
    Address
    Cary, Nc 27513 Usa, 5000 Centre Green Way Ste 100
    City
    Cary
    State
    NC
    ZIP
    27513
    Country
    US
    Email
    [email protected]
    Phone
    724 7138756

    Products

    Device Name Product Code
    Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid PIW
    Reduced- Montage Standard Electroencephalograph OMC

    Proprietary Names

    Nurochek-Pro System Nurochek Nurochek-Pro

    Establishment Types

    Manufacture Medical Device