Tecan Schweiz AG
CH-MF-000044877 · Switzerland · Männedorf
Tecan Schweiz AG is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: Veya Dx.
Authorised representative in the Union: Tecan Austria GmbH.
Devices declared under this manufacturer
- Fluent Dx 1080
- Fluent Dx 480
- Fluent Dx 780
- Veya Dx 6
- Veya Dx 9
Catalogue references include 30042094, 30042095, 30042096, 30246217, 30246218.
European nomenclature codes declared: W02079099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TECAN SCHWEIZ AG (CH) · FDA 3003402518 |
| Devices in EUDAMED | 5 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 40.0 % |
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: United States only. Tecan Schweiz AG is registered in the United States but was not found in the Canadian register.