Zetta25 AG
CH-MF-000022840 · Switzerland · Zurich
Zetta25 AG is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|
Among these devices, 11 are declared active.
Authorised representative in the Union: DS REP B.V..
Devices declared under this manufacturer
- DI Scan
- DS Core CBCT Anatomy
- DS Core Detect
- DS Core Diagnosis
- DS Core Resto
Catalogue references include 04262352350011, 04262352350028, 04262352350035, 04262352350080, 04262352351605, 04262352353517.
European nomenclature codes declared: Z11069092, Z11069082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Zetta25 AG (CH) · FDA 3029904428 |
| Devices in EUDAMED | 12 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 33.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ZETTA 25 AG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2024-02-21 |
Licence types: Single Device (3), System (1).
Licensed under: DS CORE DIAGNOSIS, DS CORE RESTO, DI SCAN, DS CORE DETECT.
North American profile: Both markets. Zetta25 AG is registered in both the United States and Canada.