BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ApolloVue S100 Image System

    Reg #: 3013399762 · FEI: 3013399762 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    APOLLO MEDICAL OPTICS, LTD.
    Registration Number
    3013399762
    FEI Number
    3013399762
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F., No.45, Ln 188, Ruiguang Rd., Neihu Dist.,
    City
    Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K201552

    Owner / Operator

    Firm Name
    Apollo Medical Optics, Ltd.
    Operator Number
    10055919
    Address
    2F., No.43, Ln 188, Ruiguang Rd., Neihu Dist.,
    City
    Taipei
    State
    TW-TPE
    Postal Code
    114
    Country
    TW
    Correspondent
    CHI HUA WU

    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, Imaging, Optical Coherence Tomography (Oct) NQQ

    Proprietary Names

    ApolloVue S100 Image System

    Establishment Types

    Manufacture Medical Device