SIBEL SAU
ES-MF-000000287 · Spain · Sabadell
SIBEL SAU is registered in the European database on medical devices as a manufacturer, with 87 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 87 |
|---|
Among these devices, 34 are declared active, 22 with a measuring function.
Devices declared under this manufacturer
- Cabina audiométrica S-Premium H
- Datospir Touch Diagnostic-D
- Datospir Touch Easy-D
- Datospir Touch Easy-F
- Filtro Bacteriano-vírico 28mm
- HG2 cajas
- HG4 cajas
- HM2 bolsa-granel
- HM2 bolsa-tiras
- Módulo Transductor Turbina COSMED
- R2L3 bolsa-tiras
- R4 bolsa-tiras
Showing 12 of 87 declared devices.
Catalogue references include 00551, 03024, 08290, 09878, 09880, 09892.
European nomenclature codes declared: Z12149002, Z12021085, Z12150180, Z12150101, Z121401, Z12150185.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 87 |
| 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 | 87 |
|---|---|
| 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. SIBEL SAU was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2024 CR 0025 | supplemented | 2029-06-20 |