BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MH-984

    Reg #: 3002808148 · FEI: 3002808148 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHIRAKAWA OLYMPUS CO., LTD.
    Registration Number
    3002808148
    FEI Number
    3002808148
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-1 Okamiyama, Odakura, NISHIGO-MURA
    City
    NISHISHIRAKAWA-GUN Fukushima
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K955404

    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
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    MH-984 OTV-S7PROH-HD-10E OTV-S7H-1N OTV-S7H-1D-F08E AR-T12Q OTV-S7PROH-HD-12E OTV-S7H-1D-L08E OTV-S7H-1D AR-TZ2 MH-999E MB-677

    Establishment Types

    Manufacture Medical Device