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 IIa | 9 |
|---|---|
| Class IIb | 73 |
Most frequent device types declared: Drop Clar, Dropsept Eye Wipes, EYECLEAN PRO, EYECLEAN TIP, Viscorib 1.0.
Among these devices, 78 are declared sterile, 1 active.
Devices declared under this manufacturer
- Aza Defence
- Bridema 5%
- Drop Clar
- Drop Therapeutic
- Drop Tonic 5%
- Drusen Off
- Lacrisun
- MiraUV
- Miren
- Ocutein ribo-hyal
- Ribohyal
- SONICA DEFENCE
Showing 12 of 82 declared devices.
Catalogue references include DCLA001S, DCLA001V, DTHE004V, DTHE008V, DTHE009V, DTHE013V.
European nomenclature codes declared: Q0299, Q02030301, M02030202, Z120499, Q02030206, V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 82 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 82 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. IROMED GROUP S.R.L. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT351643 | issued | 2031-04-13 |