This page includes the latest FDA filings for Tem Innovations G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3005792925 |
| FEI Number | 3005792925 |
| Name | TEM Innovations GmbH |
| Owner & Operator | TEM Innovations GmbH |
| Contact Address | Martin-Kollar-Strasse 15 Munich DE-BY Bayern 81829 DE |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Martin-Kollar Strasse, 15 Munich Bayern, 81829 DE |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
Device Company | Device | Date |
|---|---|---|
| Tem Innovations GmbH | ROTEM® 555202 | 2022-10-12 |
| Tem Innovations GmbH | ROTEM® 555201 | 2022-10-12 |
| Tem Innovations GmbH | ROTEM® 555502 | 2022-10-12 |
| Tem Innovations GmbH | ROTEM® 211000 | 2022-10-12 |
Tem Innovations GmbH | ROTEM Sigma Thromboelastometry System | 2022-07-08 |
| Tem Innovations GmbH | ROTEM® 201001 | 2020-02-03 |
| Tem Innovations GmbH | ROTEM® 503-05-US | 2018-07-06 |
| Tem Innovations GmbH | ROTEM® 503-25-US | 2018-07-06 |
| Tem Innovations GmbH | ROTEM® 503-24-US | 2018-07-06 |
| Tem Innovations GmbH | ROTEM® 503-10-US | 2018-07-06 |
| Tem Innovations GmbH | ROTEM® 503-09-US | 2018-07-06 |
| Tem Innovations GmbH | ROTEM® 503-06-US | 2018-07-06 |
| Tem Innovations GmbH | ROTEM® 503-04-US | 2018-07-06 |
| Tem Innovations GmbH | ROTEM® 503-02-US | 2018-07-06 |
| Tem Innovations GmbH | ROTEM® 200100-US | 2018-07-06 |
TEM Innovations GmbH | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET | 2011-09-19 |
Tem Innovations GmbH | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM | 2011-08-10 |
TEM Innovations GmbH | star-TEM | 2010-03-25 |
TEM Innovations GmbH | in-TEM Assay | 2010-03-25 |
TEM Innovations GmbH | hep-TEM Assay | 2010-03-25 |
TEM Innovations GmbH | ROTROL P | 2010-03-25 |
TEM Innovations GmbH | ROTROL N | 2010-03-25 |
TEM Innovations GmbH | ROTEM Delta Instrument | 2010-03-25 |
TEM Innovations GmbH | NATEM Assay | 2010-03-25 |
TEM Innovations GmbH | star-TEM | 2010-03-25 |
TEM Innovations GmbH | in-TEM Assay | 2010-03-25 |
TEM Innovations GmbH | hep-TEM Assay | 2010-03-25 |
TEM Innovations GmbH | ROTROL P | 2010-03-25 |
TEM Innovations GmbH | ROTROL N | 2010-03-25 |
TEM Innovations GmbH | ROTEM Delta Instrument | 2010-03-25 |
TEM Innovations GmbH | NATEM Assay | 2010-03-25 |
| NCAGE Code | CL548 | TEM INNOVATIONS GMBH |
| CAGE Code | CL548 | TEM INNOVATIONS GMBH |