BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    InSure FIT FOBT Controls

    Reg #: 3005311019 · FEI: 3005311019 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENTERIX PTY LTD.
    Registration Number
    3005311019
    FEI Number
    3005311019
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    UNIT 15/2 EDEN PARK DRIVE
    City
    NORTH RYDE New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K101831

    Owner / Operator

    Firm Name
    Enterix Inc
    Operator Number
    9042500
    Address
    236 Fernwood Avenue
    City
    Edison
    State
    NJ
    Postal Code
    08837
    Country
    US

    Products

    Device Name Product Code
    Control, Fecal Occult Blood OSL

    Proprietary Names

    InSure FIT FOBT Controls

    Establishment Types

    Manufacture Medical Device