Akzenta International SA
CH-MF-000036434 · Switzerland · Chiasso
Akzenta International SA is registered in the European database on medical devices as a manufacturer, with 309 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 309 |
|---|
Authorised representative in the Union: IQX GmbH.
Devices declared under this manufacturer
- ART|ONE
- CENTRA
- DENTAL XL
- LIKE
- ORBIS
- PRIME|ONE
- PRIME|ONE COOL BREATH
- PRODONTO
- PURE
- PURE|ONE
- ROYALDENT
- SMART|ONE
Showing 12 of 309 declared devices.
Catalogue references include 1090625, 312421, FAMAA24-AKZ-BP-K02, FAMBA24-AKZ-BL-K01, FAMDA24-AKZ-FU-K00, GLOCL60-AKZ-WH-M01.
European nomenclature codes declared: T01020204, T020604, S01020101, T010201, S01010101, Q019006.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 309 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 309 |
|---|---|
| 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. Akzenta International SA was not found in either the U.S. or the Canadian register.