BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant

    Reg #: 3003637092 · FEI: 3003637092 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    15

    Registration Details

    Registration Name
    OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant
    Registration Number
    3003637092
    FEI Number
    3003637092
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    34-3 Hirai, Hinode-machi
    City
    NISHITAMA-GUN Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K982323

    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
    Transducer, Ultrasonic, Diagnostic ITX
    Endoscopic Irrigation/Suction System OCX
    Microscope, Surgical EPT
    Duodenoscope And Accessories, Flexible/Rigid FDT
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ
    Endoscope, Accessories, Narrow Band Spectrum NWB
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Ultrasound Bronchoscope PSV
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Colonoscope And Accessories, Flexible/Rigid FDF
    System, X-Ray, Angiographic IZI
    Bronchoscope (Flexible Or Rigid) EOQ
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET

    Proprietary Names

    MAJ-1555 MAJ-2305 MAJ-2315 MH-244 MAJ-1597 CYF-VHA CYF-5 CYF-VH MAJ-207 MAJ-2304 MAJ-2307 MAJ-2308 OME-L200 OME-V200 MAJ-2303 MAJ-2301 MAJ-1218 MAJ-210 MAJ-209 MH-966 CV-180 MAJ-1934 MAJ-1957 MAJ-864 GF-UC140P-AL5 MAJ-1057

    Establishment Types

    Manufacture Medical Device