Data / Medical devices / Calibrator, Primary / Germany
FDA-registered makers of Calibrator, Primary in Germany: 5 establishments
5 establishments in Germany are registered with the FDA to make Calibrator, Primary (product code JIS). 4 have 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
- Calibrator, Primary
- Product code
- JIS
- Country
- Germany
Makers of Calibrator, Primary 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 | 4 | January 25, 2001 | 0 | 0 | 0 | api.fda.gov |
| ABBOTT GmbH | Wiesbaden Hesse, Germany | Exporter to the US, Manufacturer | 1 | April 11, 2003 | 0 | 0 | 0 | api.fda.gov |
| Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MBH | Berlin, Germany | Exporter to the US, Manufacturer | 1 | October 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 1 | November 9, 2001 | 0 | 0 | 0 | api.fda.gov |
| B.R.A.H.M.S GmbH | HENNIGSDORF Brandenburg, Germany | Specification developer | 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.