BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Enhance Plus

    Reg #: 3011927597 · FEI: 3011927597 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GN ReSound (Malaysia) Sdn Bhd.
    Registration Number
    3011927597
    FEI Number
    3011927597
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 5, Jalan i-Park 1/1, Kawasan Perindustrian i-Park
    City
    Kulai Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K213424

    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
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH

    Proprietary Names

    Enhance Plus

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)