BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    K-005

    Reg #: 3014769442 · FEI: 3014769442 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Aomori Olympus Co., Ltd. Distribution Center
    Registration Number
    3014769442
    FEI Number
    3014769442
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1-5, Ogi-Machi
    City
    Hirosaki-shi Aomori
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K984358

    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
    Gastroscope And Accessories, Flexible/Rigid FDS

    Proprietary Names

    K-005 D-201-12402 D-201-13404 K-007 K-010 D-201-16403 K-006 K-008 K-009 SD-221U-25 SD-221L-25

    Establishment Types

    Repack or Relabel Medical Device