BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    AirSense 11

    Reg #: 3009107628 · FEI: 3009107628 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PPC MOULDING SERVICES PTY LTD
    Registration Number
    3009107628
    FEI Number
    3009107628
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25 Miowera Road
    City
    Villawood New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K203126

    Owner / Operator

    Firm Name
    PPC Moulding Services Pty Ltd
    Operator Number
    10049184
    Address
    25 Miowera Road
    City
    Villawood
    State
    New South Wales
    Postal Code
    2163
    Country
    AU
    Correspondent
    Wendy Aston

    US Agent

    Business Name
    RESMED CORP.
    Contact Name
    Cecilia Silva
    Address
    9001 Spectrum Center Blvd, --
    City
    San Diego
    State
    CA
    ZIP
    92123
    Country
    US
    Email
    [email protected]
    Phone
    619 3660040

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    AirSense 11

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)