BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    trophon Sonex-HL

    Reg #: 3006564498 · FEI: 3006564498 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    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
    K103059

    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 Sonex-HL trophon EPR trophon Curved Probe Positioner

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device