Smeg S.p.A.
IT-MF-000019585 · Italy · GUASTALLA (RE)
Smeg S.p.A. is registered in the European database on medical devices as a manufacturer, with 82 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 65 |
|---|---|
| Class IIa | 17 |
Most frequent device types declared: BPW1260, BPW4260, BPW4290, Detergente, Detergente non enzimatico.
Among these devices, 75 are declared active.
Devices declared under this manufacturer
- BPW1260J-K5
- BPW1260JEK5
- BPW4260JEK5
- BPW4290J-K5
- DENTALZYM5
- DETERLQC2
- MTLD90-LC-06G
- WD4260-SC-000
- WD6010T
- WD7010M
- WD7010M6
- WD7015TECO
Showing 12 of 82 declared devices.
Catalogue references include BPW4290J-K5, DETERLQC2, MTLD90-LC-06G, WD6010T, WD7010M6, WD7015TECO.
European nomenclature codes declared: Z12011301, D0899, D99, D0801.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 82 |
| 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 | 82 |
|---|---|
| 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. Smeg S.p.A. was not found in either the U.S. or the Canadian register.