BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    NomoLine ISA OR+

    Reg #: 3027256461 · FEI: 3027256461 · Expires 2025
    View on FDA
    Products
    21
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    21

    Registration Details

    Registration Name
    Masimo Medical Technologies (Malaysia) SDN BHD
    Registration Number
    3027256461
    FEI Number
    3027256461
    Status
    Active
    Expiry Year
    2025
    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
    K171121

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

    Proprietary Names

    NomoLine ISA OR+ ISA AX+ Module NomoLine Accessories NomoLine-O Accessories NomoLine ISA CO2 ISA CO2 Module NomoLine ISA AX+

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device