IROMED GROUP S.R.L.
IT-MF-000031267 · Italy · Roma
IROMED GROUP S.R.L. is registered in the European database on medical devices as a manufacturer, with 82 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 73 |
|---|---|
| Class IIa | 9 |
Most frequent device types declared: Drop Clar, Viscorib 1.0, Dropsept Eye Wipes, EYECLEAN PRO, EYECLEAN TIP.
Among these devices, 78 are declared sterile, 1 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 | 82 |
| 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 |
|---|---|---|
IT351643 | issued | 2031-04-13 |