OKEAN ZALE S.L
ES-MF-000036705 · Spain · Alicante
OKEAN ZALE S.L is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: OZ NASAL SPRAY.
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- Linn Neusspoeling Spray
- Multipharma Neusspray Hypertone Oplossing
- Multipharma Spray Nasal Baby
- Multipharma Zeewaterspray Isotone Oplossing
- OZ HYPERTONIC NASAL SPRAY
- OZ ISOTONIC NASAL SPRAY
Catalogue references include PT385, PT386, PT424, PT428, PT433, PT446.
European nomenclature codes declared: Q030103, M9002.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 8 |
|---|---|
| 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. OKEAN ZALE S.L was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2025 PR 0048 | issued | 2030-04-14 |