BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    OLYMPUS OES LAPAROSCOPY SYSTEM

    Reg #: 9610773 · FEI: 3002807798 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    OLYMPUS WINTER & IBE GMBH
    Registration Number
    9610773
    FEI Number
    3002807798
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KUEHNSTRASSE 61
    City
    HAMBURG
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K923982

    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
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    OLYMPUS OES LAPAROSCOPY SYSTEM

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device