SODEL
FR-MF-000000367 · France · LISIEUX
SODEL is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 22 |
|---|---|
| Class IIb | 6 |
Most frequent device types declared: F3324, F3324-Surf, F3422, F3423.
Devices declared under this manufacturer
- CLEAN ONE + 2X5L
- EXEOL D ASPI 6X1L DOSEUR 20ML
- EXEOL GTA 2% 4X5L
- EXEOL SEPT E2 4X5L +1 PPE 20ML
- EXEOL SEPT E2 6X1L DOSEUR 20ML
- EXEOL SEPT E2 6X1L DOSEUR 20ML MAT
- EXEOL SEPT FIRST 4X5L+1PP 20ML MAT
- EXEOL SEPT FIRST 6X1L DOS 20ML
- EXEOL SEPT FIRST 6X1L DOS 20ML MAT
- EXEOL SURF 60 12X1L
- EXEOL SURF OPTIMAL 12X750ML
- EXEOL WIPES 60 12X100
Showing 12 of 28 declared devices.
Catalogue references include 2000000289, 2000000290, 8000.002, EXS0031FR, EXS0038BE, EXS0041Z19E.
European nomenclature codes declared: D0902, D0901, D0701, D01010102, D99, D010103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 28 |
| 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 | 28 |
|---|---|
| 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. SODEL was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40077 | issued | 2028-05-16 |
39947 | issued | 2028-05-16 |
39301 | supplemented | 2028-05-16 |