BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    HCS Dream, BTE, ITE, CIC, RIC, RITE

    Reg #: 8021514 · FEI: 3003557127 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Widex A/S
    Registration Number
    8021514
    FEI Number
    3003557127
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Nymoellevej 6
    City
    Lynge Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    DEN100025

    Owner / Operator

    Firm Name
    WS Audiology Inc.
    Operator Number
    8021514
    Address
    185 Commerce Drive
    City
    Hauppauge
    State
    NY
    Postal Code
    11788
    Country
    US
    Correspondent
    La-Shaunda Joseph

    US Agent

    Business Name
    WS Audiology
    Contact Name
    La-Shaunda Joseph
    Address
    101 Wood Avenue South, 7th Floor
    City
    Iselin
    State
    NJ
    ZIP
    08830
    Country
    US
    Email
    [email protected]
    Phone
    561 7859321

    Products

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

    Proprietary Names

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility