BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O

    Reg #: 3003591759 · FEI: 3003591759 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MBH
    Registration Number
    3003591759
    FEI Number
    3003591759
    Status
    Active
    Expiry Year
    2025
    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

    Proprietary Names

    GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O GONOTEC Standard solution 100mmol/L NaCl/H2O GONOTEC Reference Solution OSMOREF® 290mOsmol/kg NaCl/H2O

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device