BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    GN ReSound (Malaysia) Sdn Bhd.

    Reg #: 3011927597 · FEI: 3011927597 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    142
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    GN ReSound (Malaysia) Sdn Bhd.
    Registration Number
    3011927597
    FEI Number
    3011927597
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 5, Jalan i-Park 1/1, Kawasan Perindustrian i-Park
    City
    Kulai 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 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
    Masker, Tinnitus KLW
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Hearing Aid, Air-Conduction, Prescription ESD
    Face Plate Hearing Aid LRB

    Proprietary Names

    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 Tinnitus Sound Generator Module 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 Generic Faceplate

    Establishment Types

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