Data / Medical devices / Germany / TEM Innovations GmbH
TEM Innovations GmbH: FDA-registered device maker in Munich Bavaria, Germany, 3 510(k) clearances
TEM Innovations GmbH is registered with the FDA (registration 3005792925) in Munich Bavaria, Germany. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 8, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005792925
- Address
- Martin-Kollar Strasse, 15, Munich Bavaria, Germany, 81829
- Owner or operator
- TEM Innovations GmbH (10031957)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 25, 2010
- Registered through
- 2026
- Brand names listed
- EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET, NATEM Assay, ROTEM Delta Instrument, ROTEM sigma ROTROL N, ROTEM sigma ROTROL P, ROTEM sigma Thromboelastometry System, ROTEM sigma complete + hep, ROTROL N and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plasma, Coagulation Control | GGN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 8, 2022 | K201440 | ROTEM sigma Thromboelastometry System | JPA | Substantially Equivalent | Tem Innovations GmbH | accessdata.fda.gov |
| August 10, 2011 | K101533 | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM | JPA | Substantially Equivalent | Tem Innovations GmbH | accessdata.fda.gov |
| March 23, 2010 | K083842 | ROTEM DELTA THROMBOELASTOMETRY SYSTEM | JPA | Substantially Equivalent | Pentapharm GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of System, Multipurpose For In Vitro Coagulation Studies
- All makers of Plasma, Coagulation Control
Updated July 8, 2022. 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.