BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    Aveta Coral Disposable Hysteroscope

    Reg #: 3012356141 · FEI: 3012356141 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDRES MEDICAL ENGINEERING LTD.
    Registration Number
    3012356141
    FEI Number
    3012356141
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Albert Florian ut 3/b
    City
    Budapest
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K190372

    Owner / Operator

    Firm Name
    MEDRES Medical Engineering Ltd.
    Operator Number
    10061418
    Address
    Albert Florian ut 3/b
    City
    Budapest
    State
    HU-BU
    Postal Code
    1097
    Country
    HU
    Correspondent
    Krisztina Heintz

    US Agent

    Business Name
    Meditrina Inc.
    Contact Name
    Lyudmila Kokish Kokish
    Address
    1190 Saratoga Ave, Suite 180
    City
    San Jose
    State
    CA
    ZIP
    95129
    Country
    US
    Email
    [email protected]
    Phone
    408 4714877

    Products

    Device Name Product Code
    Hysteroscope (And Accessories) HIH
    Insufflator, Hysteroscopic HIG

    Proprietary Names

    Aveta Coral Disposable Hysteroscope Aveta Auto Disposable Resecting Device Aveta Opal Disposable Hysteroscope 4.6mm Aveta Pearl Disposable Hysteroscope Aveta Opal Reusable Cable Aveta Reusable Resecting Handset

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)