Sofibel
FR-MF-000003192 · France · Levallois Perret
Sofibel is registered in the European database on medical devices as a manufacturer, with 63 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 63 |
|---|
Most frequent device types declared: STÉRIMAR.
Devices declared under this manufacturer
- Stérimar ALERGIA 50 mL
- Stérimar Allergic nose 50 mL
- Stérimar Allergie 100 mL
- Stérimar Congestion Nasal baby 50 mL
- Stérimar Congestión Nasal 100 mL
- Stérimar Dry Nose 100 mL
- Stérimar Higiene Nasal 100 mL
- Stérimar Higiene Nasal bebe 100 mL
- Stérimar ORRDUGULÁSRA baby 50 mL
- Stérimar Sinusitis Very Blocked Nose 50 mL
- Stérimar Verstopfte Nase 100 mL
- Stérimar Verstopfte Nase baby 100 mL
Showing 12 of 63 declared devices.
Catalogue references include 3331300007862, 3331300011371, 3331300097269, 3331300097443, 3331300097450, 5010724001387.
European nomenclature codes declared: Q030103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 63 |
| 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 | 63 |
|---|---|
| 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. Sofibel was not found in either the U.S. or the Canadian register.