BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Widex Clear, BTE, ITE, CIC, RIC, RITE

    Reg #: 2430101 · FEI: 2430101 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WIDEX USA, INC.
    Registration Number
    2430101
    FEI Number
    2430101
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    185 Commerce Dr
    City
    Hauppauge
    State
    NY
    ZIP
    11788
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN100025

    Owner / Operator

    Firm Name
    WSAUD A/S
    Operator Number
    2430101
    Address
    Nymoellevej 6
    City
    Lynge
    State
    Hovedstaden
    Postal Code
    DK-3540
    Country
    DK

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM

    Proprietary Names

    Widex Clear, BTE, ITE, CIC, RIC, RITE Audigy AGXW Unique, BTE, ITE, CIC, RIC, RITE Widex Dream, BTE, ITE, CIC, RIC, RITE Audigy AGXw Evoke, RIC, RITE EarQ Beyond, RIC Widex Moment BTE, ITE, CIC, RIC, RITE Audigy AGXW Dream, BTE, ITE, CIC, RIC, RITE Widex UNIQUE, BTE, ITE, CIC, RIC, RITE EarQ Unique, BTE, ITE, CIC, RIC, RITE Widex EVOKE, BTE, RIC, RITE, ITE, CIC HCS Dream, BTE, ITE, CIC, RIC, RITE Regal 2, RIC, RITE Widex Magnify, BTE, ITE, CIC, RIC, RITE EarQ EVOKE, BTE, ITE, CIC, RIC, RITE Widex Beyond, RIC Widex Mind, BTE, ITE, CIC Regal, RIC, RITE Allure

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)