ITALDEVICE S.R.L.
IT-MF-000026487 · Italy · Pomezia
ITALDEVICE S.R.L. is registered in the European database on medical devices as a manufacturer, with 59 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 49 |
|---|---|
| Class IIa | 10 |
Most frequent device types declared: SOLUZIONE OFTALMICA LUBRIFICANTE (CON HPMC), Soluzione Oftalmica Lubrificante con Ipromellosa, Soluzione Oftalmica Lubrificante Lenitiva Senza conservanti, Soluzione Oftalmica Lubrificante a base di Acido Ialuronico sale sodic, Soluzione Oftalmica Lubrificante con Ipromellosa.
Among these devices, 59 are declared sterile.
Devices declared under this manufacturer
- ALORESET senza conservanti
- ARALENS
- Azaloe
- CARBOEYE TEA
- CORDEV
- ENOXOFTAL
- EYECURE
- LINKOFTAL 015 (senza conservanti)
- LTF
- OSMODROP
- Septistop
- TRIDROPS
Showing 12 of 59 declared devices.
Catalogue references include DV80CDV003, GD80CAR003, IB90TRD010, ID90KYF010, MD70ARL005, MD80ARL003.
European nomenclature codes declared: Q02030206, Q02030299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 59 |
| 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 | 1 |
|---|---|
| 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. ITALDEVICE S.R.L. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030103-00 | issued | 2029-11-05 |