BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    trophon AcuTrace Medical Insrument Tag

    Reg #: 3006564498 · FEI: 3006564498 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NANOSONICS LIMITED
    Registration Number
    3006564498
    FEI Number
    3006564498
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7-11 Talavera Road
    City
    Macquarie Park New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K173865

    Owner / Operator

    Firm Name
    Nanosonics Limited
    Operator Number
    10035569
    Address
    7-11 Talavera Road
    City
    Macquarie Park
    State
    New South Wales
    Postal Code
    2113
    Country
    AU
    Correspondent
    Tim Croft

    US Agent

    Business Name
    Nanosonics, Inc.
    Contact Name
    Ken Shaw
    Address
    7205 E 87th St
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    844 8767466

    Products

    Device Name Product Code
    High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist OUJ

    Proprietary Names

    trophon AcuTrace Medical Insrument Tag trophon AcuTrace Operator Card trophon2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device