Z-Systems AG
CH-MF-000029012 · Switzerland · Oensingen
Z-Systems AG is registered in the European database on medical devices as a manufacturer, with 127 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 74 |
|---|---|
| Class IIa | 53 |
Among these devices, 32 are declared sterile, 75 implantable, 43 reusable.
Authorised representative in the Union: Axxos GmbH.
Catalogue references include BL-A0015, BL-A1515, BL-HC, BL-OST-H, CD-DS500, G50.
European nomenclature codes declared: P01020101, Z12110180, Q01010401, Z12110102, Q010399, Q010599.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Z-SYSTEMS AG (CH) · FDA 3006948427 |
| Devices in EUDAMED | 127 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 127 |
|---|---|
| Found in the U.S. device database | 31 |
| Share | 24.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | Z-SYSTEMS AG |
North American profile: Both markets. Z-Systems AG is registered in both the United States and Canada.