Tema Sinergie S.p.a.
IT-MF-000027196 · Italy · FAENZA (RA)
Tema Sinergie S.p.a. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: RAD-INJECT γ STAND, RADIOPHARMACEUTICAL PORTABLE INFUSER, ASTER STAND, RAD-INJECT β STAND, Automatic transportable dose fractionator.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Italy |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.