BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    FITSON SDN BHD

    Reg #: 3004957421 · FEI: 3004957421 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    FITSON SDN BHD
    Registration Number
    3004957421
    FEI Number
    3004957421
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    19 Jalan I-Park SAC 3, Taman Perindustrian I-Park SAC
    City
    Senai Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K090167

    Owner / Operator

    Firm Name
    Fitson Sdn Bhd
    Operator Number
    10029016
    Address
    37 Jalan Permas 9/12,, Bandar Baru Permas Jaya
    City
    Johor Bahru
    State
    MY-01
    Postal Code
    81750
    Country
    MY

    Products

    Device Name Product Code
    Ring, Teething, Non-Fluid Filled MEF
    Pump, Breast, Non-Powered HGY
    Ring, Teething, Fluid-Filled KKO

    Proprietary Names

    Pigeon Singapore Pte Ltd Nurnberg Gummi Babyartikel GmbH & Co. Kg Allegre Puericulture SAS Laboratoires Polive Hegen Pte Ltd

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device