BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    RE-10

    Reg #: 3003637092 · FEI: 3003637092 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant
    Registration Number
    3003637092
    FEI Number
    3003637092
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    34-3 Hirai, Hinode-machi
    City
    NISHITAMA-GUN Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K183053

    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
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ

    Proprietary Names

    RE-10 MAJ-2029 MAJ-2033 MAJ-2032 MAJ-2294 MAJ-2027 MAJ-2034 MAJ-2030 MAJ-2031

    Establishment Types

    Manufacture Medical Device