OIARSO, S. COOP
ES-MF-000000866 · Spain · HERNANI
OIARSO, S. COOP is registered in the European database on medical devices as a manufacturer, with 584 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 549 |
|---|---|
| Class IIb | 35 |
Most frequent device types declared: 055.12, 056.10, 057.14, 057.16, 104.66.
Among these devices, 577 are declared sterile.
Devices declared under this manufacturer
- Bexen Medical
- Bexen medical
- FRESENIUS KABI
- Fresenius Kabi
- Kiro Oncology / Bexen Medical
- MEDIPAC
- Medozon
- Medozon Catheter
- Medozon i-set
Showing 12 of 584 declared devices.
Catalogue references include 055.12, 215.50, 223.90, 246.20, 256.35, 260.05.
European nomenclature codes declared: A080102, A03020101, G02020101, A080101, A03040201, A04010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 584 |
| 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 | 506 |
|---|---|
| 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. OIARSO, S. COOP was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2023 PR 0007 | issued | 2028-11-05 |