BACK2SLEEP
FR-MF-000034642 · France · PARIS
BACK2SLEEP is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: Back2Sleep, Stent L, Stent XL, Stent size S.
Among these devices, 1 are declared reusable.
Devices declared under this manufacturer
- Back2Sleep
- Stent L
- Stent M
- Stent S
- Stent XL
Catalogue references include B2STUB-L, B2STUB-M, B2STUB-S, B2STUB-XL.
European nomenclature codes declared: Q03010299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | France |
⚠️ 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. BACK2SLEEP was not found in either the U.S. or the Canadian register.