BIONER SA
ES-MF-000004352 · Spain · Sant Just Desvern
BIONER SA is registered in the European database on medical devices as a manufacturer, with 385 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 385 |
|---|
Most frequent device types declared: ANL, CAL, CCG, HE, SB.
Catalogue references include A-2D, C-2, C-5L, CG-THE, CI-CCiCL, PORFAM.
European nomenclature codes declared: P01020180.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 385 |
| 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 | 385 |
|---|---|
| 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. BIONER SA was not found in either the U.S. or the Canadian register.