OPERON, S.A.
ES-MF-000004790 · Spain · Cuarte de Huerva - Zaragoza
OPERON, S.A. is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 3.117.XXX.YY.ZZZ, 3.151.XXX.YY.ZZZ, 9.050.XXX.YY.ZZZ, 9.065.XXX.YY.ZZZ, 9.081.XXX.YY.ZZZ.
Devices declared under this manufacturer
- CeliacStrip
- High + Low PapillomaStrip
- SIMPLE Strep pneumo-Legio / STICK Strep pneumo-Legio
- Simple / Stick Strep A
- Simple Crypto-Giardia-Entamoeba 4R
- Simple Flu A+B
- Simple GDH-Toxins
- Simple H.pyl-Tf
- Simple RSV-Flu A+B
- Simple Rota-Adeno-Noro
- Simple Rotavirus / Stick Rotavirus
- ThromboSrip
Showing 12 of 92 declared devices.
Catalogue references include 3.117.XXX.YY.ZZZ, 9.050.020.20.000, 9.065.020.20.000, 9.134.040.71.000, 9.144.020.16.000, 9.23.1025.62.026 -.
European nomenclature codes declared: W0105099099, W0105090106, W0105090499, W0105090102, W0105090103, W0105090699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OPERON, S.A. (ES) · FDA 3007360698 |
| Devices in EUDAMED | 92 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 60 |
|---|---|
| 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: United States only. OPERON, S.A. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IX 1530337-1 | issued | 2030-04-15 |
HX 1530337-1 | supplemented | 2029-12-18 |