BEUDAMED
    FDA Registration Active 🇵🇭 Philippines

    SomnoMed Phillipines Inc.

    Reg #: 3009440973 · FEI: 3009440973 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    SomnoMed Phillipines Inc.
    Registration Number
    3009440973
    FEI Number
    3009440973
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Levels 1-3 Allegro Centre, 2284 Don Chino Roces Ave. Extension, Magallenes
    City
    Makati City National Capital Region
    Country
    PH

    Regulatory Submissions

    510(k) Number
    K150369

    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
    Ioana Gabel
    Address
    6513 Windcrest Dr Ste 100
    City
    Plano
    State
    TX
    ZIP
    75024
    Country
    US
    Email
    [email protected]
    Phone
    682 5572600 ext. 2600

    Products

    Device Name Product Code
    Sleep Appliances With Patient Monitoring PLC
    Device, Anti-Snoring LRK
    Tray, Impression, Preformed EHY
    Mouthguard, Prescription MQC
    Positioner, Tooth, Preformed KMY
    Resin, Denture, Relining, Repairing, Rebasing EBI

    Proprietary Names

    DentiTrac Virtus SomGauge SomnoDent Brux SomnoDent AVANT Herbst Advance Flex Herbst Advance Classic Herbst Shim Flex Herbst Telescopic Flex Herbst Shim Classic Herbst Telescopic Classic SomnoDent Herbst Advance Elite SomnoDent Air Classic Lingual-Less Classic Morning Repositioner Fusion Classic Fusion Flex SomnoDent Air+ Flex

    Establishment Types

    Manufacture Medical Device