Nalkein SA
CH-MF-000039092 · Switzerland · 6900 Paradiso (CH)
Nalkein SA is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Authorised representative in the Union: Nalkein Italia srl.
Devices declared under this manufacturer
- Filorin Gocce
- Filorin Gola Spray
- Filorin Spray Nasale
- Filorin Spray Nasale Iper 3%
- Fonitis Spray Auricolare
Catalogue references include FI3SPYCV.05, FIGSPYCV.08, FINGCCCV.05, FINSPYCV.09, FONSPYCV.05.
European nomenclature codes declared: Q030199, M9002, Q03040299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| Country of registration | Switzerland |
⚠️ 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. Nalkein SA was not found in either the U.S. or the Canadian register.