BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GN Hearing Care Corporation

    Reg #: 2182204 · FEI: 2182204 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    141
    Establishment Types
    5
    Classifications
    6

    Registration Details

    Registration Name
    GN Hearing Care Corporation
    Registration Number
    2182204
    FEI Number
    2182204
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5005 Dean Lakes Blvd
    City
    Shakopee
    State
    MN
    ZIP
    55379
    Country
    US

    Regulatory Submissions

    510(k) Number
    K073636

    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
    Masker, Tinnitus KLW
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Hearing Aid, Air-Conduction, Prescription ESD

    Proprietary Names

    Tinnitus Sound Generator Module Enhance Select 500 SureFit,sport lock Multi Mic Enhance Select 700 Enhance Select 200 Enhance Select 50R TV Streamer 2 Enhance Select 300 Phone Clip Plus Enhance Select 100 Enhance Select 50 Enhance Plus AGXR-E Vida OMNIA Smart Fit FM Receiver XB AGXR-XG Sentry Choice Dome LiNX Quattro ONE Enhance Max DAI Boot Vivia Enhance Pro 30 Celebrate Achieve Smart3D AGXR-XD Enhance Pro 10 First CS Smart Fit Forte MyPAL Pro DAI Shoe TV streamer+ AGXR-T Custom Charger Desktop Charger Cross Unit XE BeMore SureFit,transducer module with receiver in the ear XC Micro Mic LiNX TS BeMore Cala XH Aventa Imagine AGXR-L Commence Attune Legend Enzo 2 Lively Boost Max S Remote Control DAI ADAPTOR 3 Savi HearPlus Remote Control 2 Envision Rely Multi-Mic+ Audigy Acoustic Tubing Key Boost Plus XG Up Enhance Pro PM SureFit,acoustic tubing Enhance Pro 20 Transducer module with receiver in the ear Discover Boost Ultra AGXR-N LiNX 3D Solus Pro Astro Pro Preza Relief Peak 7 AGXR-H ENZO Q Flyte AGXR-XB LiNX 2 Enzo IA Sport Lock Enzo 3D Wax Guard Peak Pro 9 Noahlink Verso Enzo Kirkland Signature 6 Phone Link 2 Enhance Select HearMax Premium Charger Nexia Amaze Up Smart Enya Serene Ear Mold AGXR-XH SureFit,domes AGXR-XC LiNX Promise Boost Max Standard Charger Hearing Aid Battery Solus Max MyPAL Micro TV Link 2 AGXR-Q AGXR-XF Trust Enzo Core Ally Tuner Audigy 2 Enhance Pro Smart AGXR-Y DAI ADAPTOR 2 Origin Magna Bold Lex 800-M Lex 400-M SureFit CROS/BICROS Vea

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device