Data / Medical devices / Germany / Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MBH
Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MBH: FDA-registered device maker in Berlin, Germany, 1 510(k) clearance
Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MBH is registered with the FDA (registration 3003591759) in Berlin, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 21, 2003. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003591759
- Address
- Reuchlinstr. 10-11, Berlin, Germany, D-10553
- Owner or operator
- GONOTEC Gesellschaft fuer Mess- und Regeltechnik mbH (9048267)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 30, 2001
- Registered through
- 2026
- Brand names listed
- ChloroChek Chloridometer Sweat Chloride Analyzer Model 3400, ChloroChek Reagent Set, ChloroChek Standard Solution, FreezePoint® Freezing Point Osmometer, Model 6000, FreezePoint® Freezing Point Osmometer, Model 6000P, FreezePoint® Freezing Point Osmometer, Model 6000S, FreezePoint® Freezing Point Osmometer, Model 6000SP, GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Primary | JIS | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Coulometric, Chloride | JFS | 2 | Contract manufacturer | accessdata.fda.gov |
| Osmometer For Clinical Use | JJM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 21, 2003 | K032608 | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | JIS | Substantially Equivalent | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | accessdata.fda.gov |
Compare with other makers
Updated October 21, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.