BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TAKAGI SEIKO CO., LTD.

    Reg #: 9710516 · FEI: 3001802794 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    12

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    Registration Details

    Registration Name
    TAKAGI SEIKO CO., LTD.
    Registration Number
    9710516
    FEI Number
    3001802794
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    330-2 IWAFUNE
    City
    NAKANO-SHI Nagano
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K182491

    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
    Tonometer, Manual HKY
    Table, Instrument, Powered, Ophthalmic HRJ
    Biomicroscope, Slit-Lamp, Ac-Powered, Exempt PUE
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Refractor, Manual, Non-Powered, Including Phoropter HKN
    Projector, Ophthalmic HOS
    Chair, Ophthalmic, Manual HMD
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Chair, Ophthalmic, Ac-Powered HME
    Frame, Trial, Ophthalmic HPA
    Perimeter, Ac-Powered HOO
    Stand, Instrument, Ac-Powered, Ophthalmic HMF

    Proprietary Names

    MARCO AT-8 APPLANATION TONOMETER APPLANATION TONOMETER AT-2 MARCO ORION OPHTHALMIC WORKSTATION MOBILE SLIT LAMP MICROSCOPE MS1 MARCO AT-9 APPLANATION TONOMETER APPLANATION TONOMETER AT-1 OM-9 OPERATING MICROSCOPE OM-19 OPERATING MICROSCOPE OM-6 OPERATING MICROSCOPE VIEW TESTER VT-5 CHART PROJECTOR CP-40 MARCO ENCORE MANUAL CHAIR SLIT LAMP MICROSCOPE 30GL MARCO ULTRA M4 MARCO ULTRA M3 SLIT LAMP MICROSCOPE 4ZL MARCO BRAVO CHAIR MARCO TILT CHAIR MARCO ENCORE AUTOMATIC CHAIR Ellex 30XL SLITLAMP MARCO TRIAL LENS FRAME PROJECTION PERIMETER MT 325UD MARCO ULTRA M2 MARCO ULTRA M2 BI SLIT LAMP MICROSCOPE 2ZL SLIT LAMP MICROSCOPE 700GL MARCO ULTRA M5 MARCO ENCORE STAND MARCO DELUXE 2 STAND MARCO BRAVO STAND MARCO DELUXE STAND MARCO NON-CONSOLE DELUXE 2 STAND

    Establishment Types

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