BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    UPD-3

    Reg #: 9610595 · FEI: 3002964398 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    AIZU OLYMPUS CO., LTD.
    Registration Number
    9610595
    FEI Number
    3002964398
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-1-1 Niiderakita
    City
    AIZUWAKAMATSU-SHI Fukushima
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K134026

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    US Agent

    Business Name
    Gyrus ACMI, Inc.
    Contact Name
    Todd Brill
    Address
    800 West Park Drive, --
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US
    Email
    [email protected]
    Phone
    508 2077661

    Products

    Device Name Product Code
    Spatial Imaging For Display Of Endoscope Position PGU
    Enteroscope And Accessories FDA
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    UPD-3 MAJ-1898 MAJ-1878 MAJ-1890 MAJ-1938 MAJ-1881 MAJ-1880 MAJ-1899 MAJ-1879 MAJ-1907

    Establishment Types

    Manufacture Medical Device