BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    (T-Piece Resuscitator)

    Reg #: 8044169 · FEI: 1000283452 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PLAXTRON INDUSTRIAL (M) SDN. BHD.
    Registration Number
    8044169
    FEI Number
    1000283452
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PLOT 28, KAWASAN PERUSAHAAN, JELAPANG 2, FTZ
    City
    IPOH Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K093913

    Owner / Operator

    Firm Name
    PLAXTRON INDUSTRIAL (M) SDN. BHD.
    Operator Number
    9005976
    Address
    PLOT 28, KAWASAN PERUSAHAAN, JELAPANG 2, FTZ
    City
    IPOH, PERAK
    State
    MY-NOTA
    Postal Code
    30020
    Country
    MY
    Correspondent
    JAY - WANG

    Products

    Device Name Product Code
    Ventilator, Emergency, Powered (Resuscitator) BTL

    Proprietary Names

    (T-Piece Resuscitator) NEO TEE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)