BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Widex IE-ZEN

    Reg #: 8021514 · FEI: 3003557127 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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
    K110973

    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
    Masker, Tinnitus KLW

    Proprietary Names

    Widex IE-ZEN Widex Zen2Go Signia AX Signia IX

    Establishment Types

    Manufacture Medical Device