BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Achieve

    Reg #: 3026048380 · FEI: 3026048380 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    56
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GN ReSound (Malaysia) Sdn. Bhd
    Registration Number
    3026048380
    FEI Number
    3026048380
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 18, Jalan Kargo 2, Senai Airport City
    City
    Senai Johor
    Country
    MY

    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
    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

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)