BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    encevis

    Reg #: 3017374042 · FEI: 3017374042 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    AIT AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH
    Registration Number
    3017374042
    FEI Number
    3017374042
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Giefingasse 4
    City
    Vienna Wien
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K211452

    Owner / Operator

    Firm Name
    AIT Austrian Institute of Technology GmbH
    Operator Number
    10077267
    Address
    Giefingasse 4
    City
    Vienna
    State
    Wien
    Postal Code
    1210
    Country
    AT
    Correspondent
    Tilmann Kluge

    US Agent

    Business Name
    IUVO CONSULTING, LLC
    Contact Name
    Rhonda Alexander
    Address
    1820 PERLA DRIVE
    City
    Virginia Beach
    State
    VA
    ZIP
    23456
    Country
    US
    Email
    [email protected]
    Phone
    202 7928344

    Products

    Device Name Product Code
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Amplitude-Integrated Electroencephalograph OMA

    Proprietary Names

    encevis

    Establishment Types

    Manufacture Medical Device