Data / Medical devices / Electrode, Ion Specific, Potassium / Germany
FDA-registered makers of Electrode, Ion Specific, Potassium in Germany: 6 establishments
6 establishments in Germany are registered with the FDA to make Electrode, Ion Specific, Potassium (product code CEM). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Electrode, Ion Specific, Potassium
- Product code
- CEM
- Country
- Germany
Makers of Electrode, Ion Specific, Potassium in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 2 | March 13, 2006 | 0 | 0 | 0 | api.fda.gov |
| Abbott Automation Solutions GmbH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Pharma Jena | Jena Thuringia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siegfried Hameln GmbH | Hameln Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.