Schwabe Pharma Italia
IT-MF-000029129 · Italy · Verona
Schwabe Pharma Italia is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 21 |
|---|
Most frequent device types declared: KalobaGOLA, KalobaTUSS adulti, KalobaTUSS bambini, NASAL SPRAY, Spray Nasali.
Devices declared under this manufacturer
- Candinorm Idrogel Equilibra
- Candinorm PRO
- Candinorm PRO ovulos
- KalobaGOLA compresse gusto balsamico
- KalobaGOLA compresse gusto fragola
- KalobaGOLA spray
- KalobaNASO
- KalobaNASO Junior
- KalobaTUSS adulti
- KalobaTUSS adulti 180 g
- KalobaTUSS adulti campione
- KalobaTUSS bambini
Showing 12 of 21 declared devices.
Catalogue references include CNP01, CNP03, KG02, KT02, KTA-C ES, KTA-V ES.
European nomenclature codes declared: V9017, U0803, Q030199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 21 |
| 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 | 8 |
|---|---|
| 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. Schwabe Pharma Italia was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITD 1342965 1 | amended | 2028-04-09 |