BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    G.TEC MEDICAL ENGINEERING GMBH

    Reg #: 3005713796 · FEI: 3005713796 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    G.TEC MEDICAL ENGINEERING GMBH
    Registration Number
    3005713796
    FEI Number
    3005713796
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14 SIERNINGSTRASSE
    City
    SCHIEDLBERG Oberosterreich
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K123255

    Owner / Operator

    Firm Name
    G.TEC MEDICAL ENGINEERING GMBH
    Operator Number
    9084852
    Address
    14 SIERNINGSTRASSE, --
    City
    SCHIEDLBERG
    State
    AT-NOTA
    Postal Code
    4521
    Country
    AT
    Correspondent
    CHRISTOPH - GUGER

    Products

    Device Name Product Code
    Amplifier, Physiological Signal GWL
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Normalizing Quantitative Electroencephalograph Software OLU
    Electrode, Cortical GYC
    Stimulator, Muscle, Powered IPF
    Stimulator, Neuromuscular, External Functional GZI
    Electrode, Cutaneous GXY

    Proprietary Names

    g.HIamp cortiQ PRO g.Estim PRO g.ESTIM FES g.Nautilus PRO

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility