BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    DKK DAI-ICHI SHOMEI CO, LTD

    Reg #: 3006437518 · FEI: 3006437518 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    DKK DAI-ICHI SHOMEI CO, LTD
    Registration Number
    3006437518
    FEI Number
    3006437518
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-32-26, SAKASHITA
    City
    ITABASHI-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K071698

    Owner / Operator

    Firm Name
    DKK DAI-ICHI SHOMEI CO, LTD
    Operator Number
    9042505
    Address
    1-32-26, SAKASHITA,, --
    City
    ITABASHI-KU, TOKYO
    State
    JP-NOTA
    Postal Code
    174-0043
    Country
    JP

    US Agent

    Business Name
    MDI CONSULTANTS
    Contact Name
    ALAN SCHWARTZ
    Address
    55 NORTHERN BLVD, SUITE 200
    City
    GREAT NECK
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Camera, Surgical And Accessories KQM
    Device, Medical Examination, Ac Powered KZF
    Light, Surgical, Floor Standing FSS
    Light, Surgical, Ceiling Mounted FSY
    Light, Surgical, Accessories FTA

    Proprietary Names

    Remote Camera Control Unit Aurora II and newer Camera for Aurora 3 and Aurora Four Lights and Lumos series Lucina4 Series Spectra AUT1 series Aurora Series Aurora 2 Series Nautilus LED Series Stellar Series Stellar XL Series Aurora 3 Series Aurora Astro Series Aurora 4 Series Lumos series Aurora series, Aurora 2 series, Aurora 3 series and Aurora 4 series Sterilizable Camera Cover for Various Model Surgical Lights Sterilizable Center Focus Handle Sterilizable Handle/Adapter for Various Model Surgical Lights Nautilus LED series

    Establishment Types

    Manufacture Medical Device