BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    NaoTrac S

    Reg #: 3015797559 · FEI: 3015797559 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BRAIN NAVI BIOTECHNOLOGY CO., LTD.
    Registration Number
    3015797559
    FEI Number
    3015797559
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 66-1, Shengyi 5th Rd.
    City
    Zhubei City Hsinchu
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K242575

    Owner / Operator

    Firm Name
    BRAIN NAVI BIOTECHNOLOGY CO., LTD.
    Operator Number
    10081676
    Address
    No. 66-1, Shengyi 5th Rd.
    City
    Zhubei City
    State
    Hsinchu
    Postal Code
    302
    Country
    TW
    Correspondent
    Shally Lu

    US Agent

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

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    NaoTrac S

    Establishment Types

    Manufacture Medical Device