BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ORLVISION GMBH

    Reg #: 3009010438 · FEI: 3009010438 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ORLVISION GMBH
    Registration Number
    3009010438
    FEI Number
    3009010438
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gewerbestrasse 17
    City
    Lahnau Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K150248

    Owner / Operator

    Firm Name
    Orlvision GmbH
    Operator Number
    10061627
    Address
    Gewerbestrasse 17
    City
    Lahnau
    State
    Hesse
    Postal Code
    35633
    Country
    DE
    Correspondent
    Oliver Neumann

    US Agent

    Business Name
    IT Concepts LLC
    Contact Name
    Alla Balashov
    Address
    1244-B Quarry Lane
    City
    Pleasanton
    State
    CA
    ZIP
    94566
    Country
    US
    Email
    [email protected]
    Phone
    925 4010010 ext. 0

    Products

    Device Name Product Code
    Otoscope ERA
    Laryngoscope, Nasopharyngoscope EQN

    Proprietary Names

    Otoscope OX2 ORL Video Nasopharyngo-laryngoscope

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)