BEUDAMED
    FDA Registration Active 🇵🇭 Philippines

    SomnoDent Brux

    Reg #: 3009440973 · FEI: 3009440973 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SomnoMed Phillipines Inc.
    Registration Number
    3009440973
    FEI Number
    3009440973
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Allegro Center, Level 3, 2284 Pasong Tamo Extension
    City
    Makati City National Capital Region
    Country
    PH

    Regulatory Submissions

    510(k) Number
    K102909

    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
    Mouthguard, Prescription MQC

    Proprietary Names

    SomnoDent Brux

    Establishment Types

    Manufacture Medical Device