Dedalus Italia SpA
IT-MF-000009127 · Italy · Firenze
Dedalus Italia SpA is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| other | 28 |
|---|---|
| Class IIb | 26 |
| Class IIa | 6 |
Most frequent device types declared: ER4H FirstAid Web, ATMOSphere, S4P Engine, Pentagramma, HALIA.
Among these devices, 20 are declared active.
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 | 60 |
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 00290-A | issued | 2027-11-15 |