ALFAMED SRL
IT-MF-000033580 · Italy · PORTO SAN GIORGIO
ALFAMED SRL is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 10 |
|---|---|
| Class IIa | 9 |
Most frequent device types declared: ALFADEK 16/19, ALFADEK 18/09, EA3090, EAK90, IA091S.
Among these devices, 19 are declared sterile, 13 active.
Catalogue references include ALFADEK 18/09, EA3090, EAK90, IA091S, VA3540-BB, VA3540-L.
European nomenclature codes declared: K020399, N02010101, Z121301, A018099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 19 |
| 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 | 19 |
|---|---|
| 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. ALFAMED SRL was not found in either the U.S. or the Canadian register.