ANTONI CARLES S.A.
ES-MF-000001010 · Spain · VILASSAR DE MAR
ANTONI CARLES S.A. is registered in the European database on medical devices as a manufacturer, with 94 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 94 |
|---|
Most frequent device types declared: IS, OC, S3, S5, NEO².
Among these devices, 94 are declared active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ANTONI CARLES, S.A. (ES) · FDA 9710128 |
| Devices in EUDAMED | 94 |
| Country of registration | Spain |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1979224-1 | issued | 2030-10-16 |