FAMADENT, S.L.U.
ES-MF-000000270 · Spain · Vilamalla
FAMADENT, S.L.U. is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 41 |
|---|
Devices declared under this manufacturer
- ECO-CRYL COLD 2X500G R1
- ECO-CRYL COLD 8X500G R1
- ECO-CRYL COLD KIT INTRO R1V
- ECO-CRYL HOT (L) 2000ML
- ECO-CRYL HOT KIT INTRO R1V
- ECO-CRYL M (L) 500ML
- ECO-CRYL M KIT INTRO R1
- ECO-CRYL M KIT INTRO R1V
- ECO-CRYL PRO (L) 500ML
- ECO-CRYL PRO 2X500G R1V
- OBF - Caja 40 UN
- TECHNO SIN (L) 2000ML Tixo
Showing 12 of 41 declared devices.
Catalogue references include 9010-M20-R1, 9010-M20-R1V, 9015-M20-R1V, 9042-020, 9045-021-R1V, 9055-030-R1.
European nomenclature codes declared: Q010699, Q010599.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 41 |
| 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 | 41 |
|---|---|
| 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. FAMADENT, S.L.U. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ES26/000001625 | issued | 2031-02-16 |