BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    HOCHUEN MEDICAL SDN. BHD.

    Reg #: 3038610665 · FEI: 3038610665 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    HOCHUEN MEDICAL SDN. BHD.
    Registration Number
    3038610665
    FEI Number
    3038610665
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    62 Jalan I-Park SAC 6, Taman Perindustrian I-Park SAC
    City
    SENAI Johor
    Country
    MY

    Owner / Operator

    Firm Name
    Hochuen Medical Sdn. Bhd.
    Operator Number
    10093449
    Address
    62 Jalan I-Park SAC 6, Taman Perindustrian I-Park SAC
    City
    SENAI
    State
    Johor
    Postal Code
    81400
    Country
    MY

    Products

    Device Name Product Code
    2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification OQW
    Parainfluenza Multiplex Nucleic Acid Assay OOU
    Mycoplasma Pneumoniae Dna Assay System OZX
    Chlamydophila Pneumoniae Dna Assay System OZY
    Instrumentation For Clinical Multiplex Test Systems NSU
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG
    Influenza A Virus Subtype Differentiation Nucleic Acid Assay OEP
    Dna-Reagents, Neisseria LSL
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Components, Exercise IOD
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Continuous Measurement Thermometer FLL
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices QLT

    Proprietary Names

    ePlex® Respiratory Pathogen (RP) Panel binx io CT/NG Assay and binx io CT/NG System REAL Sensor Bands Metrix COVID-19 Test Tasso+, Tasso mini Fever Scout™ Continuous Monitoring Thermometer Container Metrix COVID/Flu Test, Metrix Reader

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)