BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MAJ-2551

    Reg #: 8010047 · FEI: 3002807795 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    6

    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
    K243380

    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
    Bronchoscope (Flexible Or Rigid) EOQ
    Laryngostroboscope EQL
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Led Light Source NTN
    Laparoscope, Gynecologic (And Accessories) HET

    Proprietary Names

    MAJ-2551 MAJ-2548 OTV-S500 MAJ-2547 MAJ-2550 MAJ-2549

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility