BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    Olympus Medical Products Czech

    Reg #: 3007960282 · FEI: 3007960282 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Olympus Medical Products Czech
    Registration Number
    3007960282
    FEI Number
    3007960282
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Ul Telickova 457/29
    City
    Prerov II Predmosti
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K210651

    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
    Resectoscope FJL
    Electrode, Electrosurgical, Active, Urological FAS
    Hysteroscope (And Accessories) HIH
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Endoscope, Ac-Powered And Accessories GCP
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Electrode, Electrosurgical JOS

    Proprietary Names

    Resection Electrodes with HF cable HF Resection Electrodes HF Resection Electrode Loop with Runner Electrosurgical loops Cysto-urethroscopes and forceps WB990310; WB990311; WB990210;WB990211 HF Resection Electrode CELON ENT SYSTEM HF Resection electrode, cylinder Roller Electrodes for OB/Gyn

    Establishment Types

    Manufacture Medical Device