BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Aurora series, Aurora 2 series, Aurora 3 series and Aurora 4 series

    Reg #: 3006437518 · FEI: 3006437518 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DKK DAI-ICHI SHOMEI CO, LTD
    Registration Number
    3006437518
    FEI Number
    3006437518
    Status
    Active
    Expiry Year
    2025
    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
    Light, Surgical, Ceiling Mounted FSY

    Proprietary Names

    Aurora series, Aurora 2 series, Aurora 3 series and Aurora 4 series Aurora Astro Series Lumos series

    Establishment Types

    Manufacture Medical Device