Aeffe Farmaceutici S.r.l.
IT-MF-000028925 · Italy · GORGONZOLA (MI)
Aeffe Farmaceutici S.r.l. is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 26 |
|---|---|
| Class IIb | 6 |
| Class I | 1 |
Most frequent device types declared: Microclismi con glicerolo, camomilla e malva, Supposte di glicerolo.
Devices declared under this manufacturer
- BABY WELLS Enemas pediatricos 3 g
- COOP MICROCLISMI 9 g adulti
- EUROSPITAL 2500 mg adulti
- KRUIDVAT MICRO KLYSMA
- LAEVOLAC GLICEROLO MICROCLISMI 9 g
- LAEVOLAC GLICEROLO SUPPOSTE 2500 mg adulti
- NOVA.1947 1500 mg bambini
- NOVA.1947 9 g adults
- PROCTALAX MICROENEMAS 3 G INFANTIL
- PROCTALAX MICROENEMAS 9 G ADULTO
- PROLAQ JUNIOR MICROENEMAS 3 G
- PROLAQ MICROENEMAS 9 G
Showing 12 of 33 declared devices.
Catalogue references include 041, 051, 052, 062, 190, 220.
European nomenclature codes declared: G99.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 33 |
| 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 | 6 |
|---|---|
| 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. Aeffe Farmaceutici S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT347304 | issued | 2030-11-16 |