BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    GN ReSound (Malaysia) Sdn. Bhd

    Reg #: 3026048380 · FEI: 3026048380 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    141
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    GN ReSound (Malaysia) Sdn. Bhd
    Registration Number
    3026048380
    FEI Number
    3026048380
    Status
    Active
    Expiry Year
    2026
    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
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH
    Face Plate Hearing Aid LRB
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM

    Proprietary Names

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

    Establishment Types

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