BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ePlex® Respiratory Pathogen (RP) Panel

    Reg #: 3038610665 · FEI: 3038610665 · Expires 2025
    View on FDA
    Products
    10
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    HOCHUEN MEDICAL SDN. BHD.
    Registration Number
    3038610665
    FEI Number
    3038610665
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    62 Jalan I-Park SAC 6, Taman Perindustrian I-Park SAC
    City
    SENAI Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K163636

    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

    US Agent

    Business Name
    MEDRIGHT TECH INC
    Contact Name
    Jessie Yao
    Address
    6302 FORT HAMILTON PARKWAY, 1R
    City
    Brooklyn
    State
    NY
    ZIP
    11219
    Country
    US
    Email
    [email protected]
    Phone
    718 2169957

    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
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Influenza A Virus Subtype Differentiation Nucleic Acid Assay OEP
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG

    Proprietary Names

    ePlex® Respiratory Pathogen (RP) Panel

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)