Nelthema srls
IT-MF-000051529 · Italy · Cassano Magnago
Nelthema srls is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Among these devices, 4 are declared active.
Devices declared under this manufacturer
- 88MC.N
- Excellence II
- Exclusive II
- New Simplex III
- Newline II
Catalogue references include 50AB.N, 63DS.N, 65PC.N, 65SA.N, 88AD.N, 88HE.N.
European nomenclature codes declared: Z12120199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| 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 | 12 |
|---|---|
| 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. Nelthema srls was not found in either the U.S. or the Canadian register.