BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Key

    Reg #: 3026048380 · FEI: 3026048380 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    119
    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 With Wireless Technology, Prescription OSM

    Proprietary Names

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

    Establishment Types

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