FDA device listing
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET
FDA device listing 1115717330 · TEM Innovations GmbH
Key facts
| Proprietary names | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET |
|---|---|
| Owner/operator | TEM Innovations GmbH |
| Owner/operator number | 10031957 |
| Premarket submissions | K101533 |
| Product codes | JPA |
| Device names | JPA - System, Multipurpose For In Vitro Coagulation Studies |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5425 |
| Review panels | Hematology |
| Registered establishments | TEM Innovations GmbH |
| Establishment registrations | 3005792925 |
| FEI numbers | 3005792925 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database