A.T.S. Applicazione Tecnologie Speciali s.r.l.
IT-MF-000010734 · Italy · Torre de' Roveri
A.T.S. Applicazione Tecnologie Speciali s.r.l. is registered in the European database on medical devices as a manufacturer, with 139 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 137 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: ARCO FP, ARCO FP-Rk2030S, ARCO FP-S, CARMEX RK FP, CYBERBLOC FP.
Among these devices, 139 are declared active.
Devices declared under this manufacturer
- Arcovis DRF
- Arcovis DRF-C
- Cyberbloc FP
- FDX Visionary C
- HIRIS RF43-FL
- ITALRAY CARMEX RK FP
- OMNISCOP DReam
- OMNISCOP DReam-S
- PRIMAX INTERNATIONAL CYBERBLOC FP
- PRIMAX INTERNATIONAL CYBERBLOC FP-S
- Persona CS
- STEPHANIX OMNISCOP Dream
Showing 12 of 139 declared devices.
Catalogue references include 74 09 000-1; 74 11 000-1, 74 09 000-2 / 74 11 000-2, 74 09 000-2; 74 11 000-2, 74 09 000-3; 74 11 000-3, 74 10 000-3; 74 12 000-3; 74 14 000; 74 15 000, 95 01 000 / 95 03 000 / 95 06 000 / 95 08 000.
European nomenclature codes declared: Z11039017, Z119007, Z11039006, Z11031192, Z11031101, V0899.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | A.T.S. Applicazione Tecnologie Speciali s.r.l. (IT) · FDA 3011347852 |
| Devices in EUDAMED | 139 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 139 |
|---|---|
| Found in the U.S. device database | 25 |
| Share | 18.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L. |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 2 |
| First licensed | 2019-05-23 |
Licence types: Device Family (2), Single Device (1).
Licensed under: ARCO FP, HIRIS RF43-FL, ARCO FP-S.
North American profile: Both markets. A.T.S. Applicazione Tecnologie Speciali s.r.l. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 2492603 1 | supplemented | 2028-12-10 |