Data / Medical devices / System, Multipurpose For In Vitro Coagulation Studies / Germany
FDA-registered makers of System, Multipurpose For In Vitro Coagulation Studies in Germany: 5 establishments
5 establishments in Germany are registered with the FDA to make System, Multipurpose For In Vitro Coagulation Studies (product code JPA). 2 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
- System, Multipurpose For In Vitro Coagulation Studies
- Product code
- JPA
- Country
- Germany
Makers of System, Multipurpose For In Vitro Coagulation Studies in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer, Specification developer | 9 | January 26, 2009 | 0 | 0 | 0 | api.fda.gov |
| TEM Innovations GmbH | Munich Bavaria, Germany | Manufacturer, Specification developer | 3 | July 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Bernd Richter GMBH | Wipperfuerth North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BIT Analytical Solutions GmbH | SCHWALBACH/TAUNUS Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tcoag Deutschland GMBH | LEMGO North Rhine-Westphalia, 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.