BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Tinnitus Sound Generator Module

    Reg #: 3005650109 · FEI: 3005650109 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GN Hearing A/S
    Registration Number
    3005650109
    FEI Number
    3005650109
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LAUTRUPBJERG 7
    City
    BALLERUP Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K180495

    Owner / Operator

    Firm Name
    GN Hearing A/S
    Operator Number
    2182204
    Address
    Lautrupbjerg 7
    City
    Ballerup
    State
    Hovedstaden
    Postal Code
    2750
    Country
    DK
    Correspondent
    Pernille Bartel

    Products

    Device Name Product Code
    Masker, Tinnitus KLW

    Proprietary Names

    Tinnitus Sound Generator Module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device