BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MBH

    Reg #: 3003591759 · FEI: 3003591759 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MBH
    Registration Number
    3003591759
    FEI Number
    3003591759
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Reuchlinstr. 10-11
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K032608

    Owner / Operator

    Firm Name
    GONOTEC Gesellschaft fuer Mess- und Regeltechnik mbH
    Operator Number
    9048267
    Address
    Reuchlinstr. 10-11, --
    City
    BERLIN
    State
    DE-BE
    Postal Code
    10553
    Country
    DE
    Correspondent
    Florian Bornschein

    Products

    Device Name Product Code
    Calibrator, Primary JIS
    Osmometer For Clinical Use JJM
    Coulometric, Chloride JFS

    Proprietary Names

    GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O GONOTEC Reference Solution OSMOREF® 290mOsmol/kg NaCl/H2O FreezePoint® Freezing Point Osmometer, Model 6000S FreezePoint® Freezing Point Osmometer, Model 6000P FreezePoint® Freezing Point Osmometer, Model 6000 FreezePoint® Freezing Point Osmometer, Model 6000SP ChloroChek Reagent Set ChloroChek Chloridometer Sweat Chloride Analyzer Model 3400 ChloroChek Standard Solution

    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)