BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MARCO ULTRA M2

    Reg #: 9710516 · FEI: 3001802794 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TAKAGI SEIKO CO., LTD.
    Registration Number
    9710516
    FEI Number
    3001802794
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    330-2 IWAFUNE
    City
    NAKANO-SHI Nagano
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K152535

    Owner / Operator

    Firm Name
    TAKAGI SEIKO CO., LTD.
    Operator Number
    9025906
    Address
    330-2 IWAFUNE, --
    City
    NAKANO-SHI, NAGANO
    State
    JP-NOTA
    Postal Code
    383-8585
    Country
    JP
    Correspondent
    TORU - HAGIWARA

    Products

    Device Name Product Code
    Biomicroscope, Slit-Lamp, Ac-Powered HJO

    Proprietary Names

    MARCO ULTRA M2 SLIT LAMP MICROSCOPE 700GL MARCO ULTRA M2 BI MARCO ULTRA M5 SLIT LAMP MICROSCOPE 2ZL

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device