BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    The iNAP One Sleep Therapy System

    Reg #: 3014674517 · FEI: 3014674517 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SOMNICS, INC.
    Registration Number
    3014674517
    FEI Number
    3014674517
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5F, No. 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,
    City
    Zhubei City Hsinchu
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K220907

    Owner / Operator

    Firm Name
    Somnics, Inc.
    Operator Number
    10058120
    Address
    5F, No. 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,
    City
    Zhubei City
    State
    Hsinchu
    Postal Code
    30261
    Country
    TW

    US Agent

    Business Name
    Dynamic Biotech Inc.
    Contact Name
    Feng-Yu Lee
    Address
    29122 Rancho Viejo Rd., Suite 212
    City
    San Juan Capistrano
    State
    CA
    ZIP
    92675
    Country
    US
    Email
    [email protected]
    Phone
    949 2180929

    Products

    Device Name Product Code
    Intraoral Pressure Gradient Device OZR

    Proprietary Names

    The iNAP One Sleep Therapy System iBreath

    Establishment Types

    Manufacture Medical Device