BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    CV-190

    Reg #: 3002808148 · FEI: 3002808148 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

    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
    K131780

    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
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Gastroscope And Accessories, Flexible/Rigid FDS
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    CV-190 CF-HQ190I CF-HQ190L CLV-190 PCF-PH190L MH-438 PCF-H190I CF-H190I MAJ-215 MAJ-1817 PCF-PH190I MAJ-1933 CF-H190L PCF-H190L

    Establishment Types

    Manufacture Medical Device