BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    RD SET TFA-1

    Reg #: 3027256461 · FEI: 3027256461 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    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
    K160940

    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

    Proprietary Names

    RD SET TFA-1 M-LNCS Red TFA-1 LNCS TFA-1 M-LNCS TFA-1

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device