BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Enhance Plus

    Reg #: 2182204 · FEI: 2182204 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GN Hearing Care Corporation
    Registration Number
    2182204
    FEI Number
    2182204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8001 E Bloomington Freeway
    City
    BLOOMINGTON
    State
    MN
    ZIP
    55420
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213424

    Owner / Operator

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

    Products

    Device Name Product Code
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH

    Proprietary Names

    Enhance Plus

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198