ATENA LUX S.R.L.
IT-MF-000016765 · Italy · GRUARO
ATENA LUX S.R.L. is registered in the European database on medical devices as a manufacturer, with 67 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 67 |
|---|
Among these devices, 67 are declared active.
Devices declared under this manufacturer
- AIRWALL CALL
- AIRWALL CALL MED
- ARMONIA .2
- ARMONIA G.2
- AUXILIA G.2
- AUXILIA GS.2
- AUXILIA LG.2
- AUXILIA LGS
- SANIMED GF.2
- SENSE S.2
- THERAPY S
- THERAPY SG.2
Showing 12 of 67 declared devices.
Catalogue references include 4251-----, 4254-----, SENSE_0000 REV.X, SNM_0000 REV.X, ST_AR_0000 REV.X, ST_AX_0000 REV.0.
European nomenclature codes declared: Z129017.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 67 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 67 |
|---|---|
| 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. ATENA LUX S.R.L. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
015-00-00-MDR | issued | 2028-03-20 |