SC SPD STAR SRL
RO-MF-000004404 · Romania · CASEIU
SC SPD STAR SRL is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 20 |
|---|---|
| other | 14 |
Among these devices, 19 are declared sterile.
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 | 34 |
| Country of registration | Romania |
⚠️ 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR.2292-2025/0006 | issued | 2030-04-14 |