Data / Medical devices / Analyzer, Chemistry (Photometric, Discrete), For Clinical Use / Germany
FDA-registered makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use in Germany: 10 establishments
10 establishments in Germany are registered with the FDA to make Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE). 2 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Product code
- JJE
- Country
- Germany
Makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 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 | 1 | June 14, 1996 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 1 | June 14, 1996 | 0 | 0 | 0 | api.fda.gov |
| Abbott Automation Solutions GmbH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Biomedical GmbH | Baierbrunn Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Biomedical GmbH | Munchen Bavaria, Germany | Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| DiaSorin Deutschland GmbH | Dietzenbach Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stratec Se | BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, 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.