BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    BlueCheck

    Reg #: 3033588343 · FEI: 3033588343 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Incisive Technologies Pty Ltd
    Registration Number
    3033588343
    FEI Number
    3033588343
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 William Street
    City
    Ferntree Gully Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K222560

    Owner / Operator

    Firm Name
    Incisive Technologies Pty Ltd
    Operator Number
    10091851
    Address
    Level 6, 41 Exhibition Street
    City
    Melbourne
    State
    Victoria
    Postal Code
    3000
    Country
    AU

    US Agent

    Business Name
    PaxMed International LLC
    Contact Name
    Floyd Larson
    Address
    1925 Palomar Oaks Way Ste 210
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US
    Email
    [email protected]
    Phone
    858 7921235

    Products

    Device Name Product Code
    Device, Caries Detection LFC

    Proprietary Names

    BlueCheck

    Establishment Types

    Manufacture Medical Device