BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MAJ-1912

    Reg #: 9610773 · FEI: 3002807798 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    5

    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
    K193026

    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
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Laparoscope, Gynecologic (And Accessories) HET
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Endoscope, Rigid GCM

    Proprietary Names

    MAJ-1912 Visera Elite II Endoeye 3D MAJ-1921

    Establishment Types

    Manufacture Medical Device