BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ChloroChek Chloridometer Sweat Chloride Analyzer Model 3400

    Reg #: 3003591759 · FEI: 3003591759 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    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
    K121823

    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
    Coulometric, Chloride JFS

    Proprietary Names

    ChloroChek Chloridometer Sweat Chloride Analyzer Model 3400 ChloroChek Reagent Set ChloroChek Standard Solution

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)