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    FDA Registration Active 🇲🇾 Malaysia

    Masimo Medical Technologies (Malaysia) SDN BHD

    Reg #: 3027256461 · FEI: 3027256461 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    23

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    Registration Details

    Registration Name
    Masimo Medical Technologies (Malaysia) SDN BHD
    Registration Number
    3027256461
    FEI Number
    3027256461
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lot 198511 (PLO 547-A) & Lot 198512 (PLO 547-B), Jalan Keluli 11, Zon 12A Kawasan Perindustrian Pasir Gudang
    City
    Pasir Gudang Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K121912

    Owner / Operator

    Firm Name
    MASIMO CORPORATION
    Operator Number
    9031881
    Address
    52 Discovery, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Mathew Jimenez

    US Agent

    Business Name
    MASIMO CORPORATION
    Contact Name
    Mathew Jimenez
    Address
    52 Discovery, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 2977000

    Products

    Device Name Product Code
    Oximeter DQA
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Breathing Frequency BZQ
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide JKS
    Electrode, Cutaneous GXY
    Cannula, Nasal, Oxygen CAT
    Full-Montage Standard Electroencephalograph GWQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Burst Suppression Detection Software For Electroencephalograph ORT
    Oximeter, Ear DPZ
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Reduced- Montage Standard Electroencephalograph OMC
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Hyperoxia Monitoring Device Adjunct To Pulse Oximetry QWE

    Proprietary Names

    MLNCS E1 LNCS E1 M-LNCS Blue LNCS Blue RD SET Multisite Reusable sensors RD Speciality sensors RD SET Reusable sensors RD SET Disposable sensors RD SET Neo RD SET DBI DBI-dc LNCS DBI Red DBI M-LNCS DBI RD SET CS Disposable Sensors LNCS Disposable Sensors M-LNCS Disposable Sensors RD SET TFA-1 M-LNCS TFA-1 LNCS TFA-1 M-LNCS Red TFA-1 LNCS YI M-LNCS YI Red Reusable Sensors LNCS Reusable Sensors M-LNCS Reusable Sensors NomoLine ISA CO2 NomoLine-O Accessories ISA CO2 Module NomoLine ISA OR+ NomoLine ISA AX+ NomoLine Accessories ISA AX+ Module RD SET TF-I M-LNCS TF-I LNCS TF-I RD rainbow Lite SET-1 RD rainbow 4 Lambda RD rainbow SET-2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device