BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    WS Audiology A/S

    Reg #: 8021514 · FEI: 3003557127 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    WS Audiology A/S
    Registration Number
    8021514
    FEI Number
    3003557127
    Status
    Active
    Expiry Year
    2026
    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
    Nymoellevej 6
    City
    Lynge
    State
    Hovedstaden
    Postal Code
    DK-3540
    Country
    DK
    Correspondent
    Isabel Restivo

    US Agent

    Business Name
    WS Audiology
    Contact Name
    Isabel Restivo
    Address
    101 Wood Avenue South, 7th Floor
    City
    Iselin
    State
    NJ
    ZIP
    08830
    Country
    US
    Email
    [email protected]
    Phone
    551 5799581

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Masker, Tinnitus KLW
    Hearing Aid, Air-Conduction, Prescription ESD

    Proprietary Names

    Widex Enjoy Widex Widex Allure Widex Magnify Widex CROS Widex Evoke Widex Moment

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device