BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Enhance Select 200

    Reg #: 3026048380 · FEI: 3026048380 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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, Over The Counter QUG

    Proprietary Names

    Enhance Select 200 TV Streamer 2 Enhance Select 100 Enhance Select 500 Enhance Select 50R Enhance Select 300 Multi Mic Enhance Select 50 SureFit,sport lock Phone Clip Plus

    Establishment Types

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