Tem Innovations GmbH
DE-MF-000012176 · Germany · Munich
Tem Innovations GmbH is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 200011, 200100, 211000, 400040, 400041.
Devices declared under this manufacturer
- Cup & Pin pro
- ROTEM® delta
- ROTEM® sigma
- ROTROL N
- ROTROL P
- TIPTRAY Refill eLine
- TRIPTRAY Box eLine
- ap-tem
- fib-tem
- hep-tem
- in-tem
- r ex-tem
Showing 12 of 13 declared devices.
Catalogue references include 211000, 400040, 400041, 503-02, 503-04, 503-06.
European nomenclature codes declared: W0103020899, W0503020280, W010302080501, W0202029001, W0503010280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TEM Innovations GmbH (DE) · FDA 3005792925 |
| Devices in EUDAMED | 13 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| Found in the U.S. device database | 10 |
| Share | 76.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TEM INNOVATIONS GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2012-09-17 |
Licence types: System (2).
Licensed under: ROTEM DELTA WHOLE BLOOD HAEMOSTASIS SYSTEM USI, ROTEM SIGMA.
North American profile: Both markets. Tem Innovations GmbH is registered in both the United States and Canada.