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: FS-1, IS, NEO², OC, Reclining Chair.
Among these devices, 94 are declared active.
Devices declared under this manufacturer
- ATE-860
- ATE-S Table
- Ancar 3100
- CH-51-N
- GR-801
- GR-860
- GR-861
- IC-1
- IS-1 (right grey)
- IS-1P (left grey)
- NEO²
- OC-100 Lite
Showing 12 of 94 declared devices.
Catalogue references include 1201313, 1202504, 4000006, 42-0004178, 8000429, 8000437.
European nomenclature codes declared: Z12129001, Z12120119, Z12110101, V08020101.
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 |
Device-level evidence
| Devices with a numeric GTIN | 94 |
|---|---|
| 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. ANTONI CARLES S.A. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1979224-1 | issued | 2030-10-16 |