BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Enhance Plus

    Reg #: 3026048380 · FEI: 3026048380 · 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
    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

    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)