BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Achieve

    Reg #: 2182204 · FEI: 2182204 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    56
    Establishment Types
    3
    Classifications
    1

    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

    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
    Hearing Aid, Air-Conduction, Prescription ESD

    Proprietary Names

    Achieve Imagine Forte Ally Magna Promise Rely Trust Flyte Celebrate Sport Lock Cala AGXR-Y AGXR-L Smart Fit Key Vea Enhance Pro 10 Peak Pro 9 Solus Pro SureFit,transducer module with receiver in the ear DAI ADAPTOR 2 Nexia Bold ONE Peak 7 Solus Max Enhance Pro 20 Wax Guard Aventa XE BeMore LiNX 3D Ear Mold Vida Lex 800-M Enya AGXR-XD Origin LiNX 2 Lex 400-M OMNIA Serene Verso SureFit,acoustic tubing AGXR-XB Legend AGXR-XF Transducer module with receiver in the ear SureFit,domes SureFit CROS/BICROS Dome SureFit,sport lock AGXR-T Hearing Aid Battery Sentry CS Smart Fit

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device