BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    SomnoDent AVANT

    Reg #: 3005343849 · FEI: 3005343849 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SOMNOMED, LTD.
    Registration Number
    3005343849
    FEI Number
    3005343849
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LEVEL 3, 20 CLARKE ST.
    City
    CROWS NEST New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K183443

    Owner / Operator

    Firm Name
    SOMNOMED INC.
    Operator Number
    9071127
    Address
    6513 Windcrest Drive, Suite #100
    City
    Plano
    State
    TX
    Postal Code
    75024
    Country
    US
    Correspondent
    Mary Kennell

    US Agent

    Business Name
    SomnoMed
    Contact Name
    Matthew Baris
    Address
    6513 Windcrest Dr Ste 100
    City
    Plano
    State
    TX
    ZIP
    75024
    Country
    US
    Email
    [email protected]
    Phone
    281 5152925

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK
    Sleep Appliances With Patient Monitoring PLC

    Proprietary Names

    SomnoDent AVANT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility