BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MAJ-1517

    Reg #: 9610595 · FEI: 3002964398 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    1

    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
    K103264

    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
    Accessories, Cleaning, For Endoscope FEB

    Proprietary Names

    MAJ-1517 MAJ-1545 MAJ-1498 MAJ-2131 MAJ-1969 MAJ-1505 MAJ-1508 MAJ-1970 MAJ-1546 MAJ-1764 MAJ-1971 MAJ-1512 MAJ-1497 MAJ-2124 MAJ-1504 MAJ-1503 OER-PRO MAJ-1513 MAJ-1515 MAJ-1514 OER-Pro MAJ-1511 MAJ-1516 MAJ-1904

    Establishment Types

    Manufacture Medical Device