Olea Medical S.A.S.
FR-MF-000002403 · France · La Ciotat
Olea Medical S.A.S. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 |
|---|
Among these devices, 10 are declared active.
Devices declared under this manufacturer
- AI DWI Mismatch V1.0
- CT Perfusion V1.0
- Functional MR V1.0
- MR DWI/FLAIR Measurement V1.0
- MR Diffusion Perfusion Mismatch V1.0
- Neuro Insight V1.0
- Neurovascular Insight V1.0
- Olea S.I.A. Neurovascular V1.0
- Olea Sphere V3.0
- breastscape V1.0
Catalogue references include AP-NV-AIDM-MR, AP-NV-CTP, AP-NV-DF-MR, AP-NV-FR-CT;AP-NV-FR-MR, AP-NVI-CT; AP-NVI-MR, MOD001;MOD002;MOD003;MOD004;MOD005;MOD007;MOD008;MOD010;MOD011;MOD012;.
European nomenclature codes declared: Z11050182.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. Olea Medical S.A.S. was not found in either the U.S. or the Canadian register.