BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OER-MINI

    Reg #: 8010047 · FEI: 3002807795 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Registration Number
    8010047
    FEI Number
    3002807795
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K120357

    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

    OER-MINI MAJ-2003 MAJ-1838 MAJ-1937 MAJ-1837 MAJ-1836 MAJ-1514 MAJ-1516 MAJ-1513 MAJ-1515 MAJ-1511 MAJ-1904

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility