SEFAM
FR-MF-000009061 · France · Neuilly-sur-Seine
SEFAM is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 21 |
|---|
Most frequent device types declared: S.Box.
Among these devices, 21 are declared active.
Devices declared under this manufacturer
- Humidificateur Chauffant S.Box
- Néa Duo ST
- Néa H2O
- Néa Info
- PolyLink
- Reve Auto
- Reve H2O
- Reve Info
- S.Box
- S.Box Duo ST
- Sefam Access Pro
- Sefam Analyze
Showing 12 of 21 declared devices.
Catalogue references include M-116412, M-116414, M-117011, M-117021, M-117023, M-120200.
European nomenclature codes declared: Z12030102, Z12030103, R060201, Z1203019082, Z129012.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 21 |
| 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 | 21 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 4.8 % |
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SEFAM |
North American profile: Canada only. SEFAM holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
39439 | supplemented | 2028-10-15 |