BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    OPXION TECH. INCORPORATION

    Reg #: 3042929028 · FEI: 3042929028 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    OPXION TECH. INCORPORATION
    Registration Number
    3042929028
    FEI Number
    3042929028
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14F-4, No. 266, Sec. 1,, Wenhua 2nd Rd
    City
    Linkou Dist New Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K242924

    Owner / Operator

    Firm Name
    OPXION Tech. Incorporation
    Operator Number
    10094965
    Address
    14F-4, No. 266, Sec. 1,, Wenhua 2nd Rd
    City
    Linkou Dist
    State
    New Taipei
    Postal Code
    244257
    Country
    TW
    Correspondent
    Bo-Huei Huang

    Products

    Device Name Product Code
    System, Imaging, Optical Coherence Tomography (Oct) NQQ

    Proprietary Names

    OPXION Optical Skin Viewer

    Establishment Types

    Manufacture Medical Device