EURONDA S.P.A.
IT-MF-000007762 · Italy · Montecchio Precalcino
EURONDA S.P.A. is registered in the European database on medical devices as a manufacturer, with 777 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 724 |
|---|---|
| Class IIb | 53 |
Most frequent device types declared: EM15 SALIVA EJECTOR, STERILIZATION ROLLS, EM19, Monoart® Nitrile Gloves, EM21.
Among these devices, 54 are declared sterile, 42 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 | 777 |
| 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 |
|---|---|---|
008/MDR | supplemented | 2026-09-21 |