OPKO HEALTH SPAIN S.L.U.
ES-MF-000014342 · Spain · L'Hospitalet de Llobregat
OPKO HEALTH SPAIN S.L.U. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 4 |
|---|---|
| Class I | 3 |
| Class IIa | 2 |
Among these devices, 9 are declared sterile.
Devices declared under this manufacturer
- Vis Activ Monodose
- Vis Activ Neo
- Vis Activ Uso Continuo
- Vis Glyc Monodosis
- Vis Glyc Neo
- Vis Relax Monodose
- Vis Relax Neo
- Vis Relax Uso Continuo
Catalogue references include EMDN- EUDAMED + DYNA, EMDN-EUDAMED+DYNA.
European nomenclature codes declared: Q02030206.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| 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. OPKO HEALTH SPAIN S.L.U. was not found in either the U.S. or the Canadian register.