MONTEFARMACO OTC SPA
IT-MF-000013309 · Italy · BOLLATE
MONTEFARMACO OTC SPA is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 11 |
|---|---|
| Class IIa | 6 |
Most frequent device types declared: AFOMILL ANTIARROSSAMENTO MONODOSE, AFOMILL ANTIARROSSAMENTO PLURIDOSE SENZA CONSERVANTI, AFOMILL RINFRESCANTE LENITIVO – flacone da 10 ml con conservanti;, AFOMILL RINRESCANTE LENITIVO - flacone da 10 ml senza conservanti, CHETOSIL.
Among these devices, 11 are declared sterile, 3 active.
Devices declared under this manufacturer
- AFOMILL
- AFOMILL REVIGORANT
- Afomill Decongestionant
- CHETOSIL
- IRIDIL
- IRIDINA GOCCE LUBRIFICANTI
- IRILENS
- IRILENS GOCCE OCULARI
- NOK SAN
- POLAROID
Showing 12 of 17 declared devices.
Catalogue references include 01675, 02364, 02616, 03622, 04720-04703, 517.
European nomenclature codes declared: Q0299, Y214599, V9099, M9002.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. MONTEFARMACO OTC SPA was not found in either the U.S. or the Canadian register.