BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    IXENSOR CO LTD

    Reg #: 3011061417 · FEI: 3011061417 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    8

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    Registration Details

    Registration Name
    IXENSOR CO LTD
    Registration Number
    3011061417
    FEI Number
    3011061417
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd.,, Neihu Dist,
    City
    Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K163087

    Owner / Operator

    Firm Name
    iXensor Co Ltd
    Operator Number
    10048224
    Address
    11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd.,, Neihu Dist,
    City
    Taipei
    State
    TW-TPE
    Postal Code
    114
    Country
    TW

    US Agent

    Business Name
    Dynamic Biotech Inc.
    Contact Name
    Feng-Yu Lee
    Address
    29122 Rancho Viejo Rd., Suite 212
    City
    San Juan Capistrano
    State
    CA
    ZIP
    92675
    Country
    US
    Email
    [email protected]
    Phone
    949 2180929

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Ldl & Vldl Precipitation, Hdl LBR
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Ventilatory Effort Recorder MNR
    Colorimetric Method, Triglycerides JGY
    Assay, Glycosylated Hemoglobin LCP
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    PixoTest PixoTest Vision Analysis System Eveline CVSHealth

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility