Bacciflex srl
IT-MF-000047829 · Italy · Campi Bisenzio
Bacciflex srl is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 38 |
|---|
Devices declared under this manufacturer
- Cuscino Memory 8
- Cuscino memory 12
- Materasso EGO
- Materasso LUX
- Materasso Plus
- Materasso SBM
- Materasso XL
- Materasso zenO+
- Topper Airplus
- Topper Biomemory
- Topper Lux
- Topper XM
Showing 12 of 38 declared devices.
Catalogue references include Cuscino Memory 8, LUX, Materasso Plus, Materasso zenO smart, Materasso zenO+, Topper Airplus.
European nomenclature codes declared: V080702, V080302.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 38 |
| 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 | 38 |
|---|---|
| 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. Bacciflex srl was not found in either the U.S. or the Canadian register.