BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ARGOS ver 1.5

    Reg #: 3012423824 · FEI: 3012423824 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    santec OIS Corporation
    Registration Number
    3012423824
    FEI Number
    3012423824
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5823 Ohkusa-Nenjozaka
    City
    Komaki Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K191051

    Owner / Operator

    Firm Name
    Santec Photonics Laboratory / Movu
    Operator Number
    10050106
    Address
    2350 Mission College Blvd. ,STE 1070
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Changho Chong

    US Agent

    Business Name
    santec U.S.A. Corporation
    Contact Name
    Changho Chong
    Address
    2350 Mission College Blvd., STE1070
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US
    Email
    [email protected]
    Phone
    408 3145079

    Products

    Device Name Product Code
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Device, Analysis, Anterior Segment MXK

    Proprietary Names

    ARGOS ver 1.5

    Establishment Types

    Manufacture Medical Device