OptimHal-ProtecSom
FR-MF-000000918 · France · VALOGNES
OptimHal-ProtecSom is registered in the European database on medical devices as a manufacturer, with 224 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 224 |
|---|
Most frequent device types declared: Housse anti-acariens pour les patients allergiques aux acariens. Marqu.
Devices declared under this manufacturer
- Couette anti-acariens Texaal®
Showing 12 of 224 declared devices.
Catalogue references include 03760079800624, 03760079801942, 03760079802413, 03760079802772, 03760079802918, 03760079802987.
European nomenclature codes declared: T0299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 224 |
| 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 | 224 |
|---|---|
| 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. OptimHal-ProtecSom was not found in either the U.S. or the Canadian register.