PreAnalytiX GmbH
CH-MF-000033445 · Switzerland · Hombrechtikon
PreAnalytiX GmbH 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: 761165, 762165, 768165.
Among these devices, 3 are declared sterile.
Authorised representative in the Union: QIAGEN GmbH.
Devices declared under this manufacturer
- PAXgene
- PAXgene Blood RNA Kit
- QIAsymphony PAXgene Blood ccfDNA Kit
Catalogue references include 761165, 762165, 762174, 768165, 768566.
European nomenclature codes declared: W050101010201, W0105900101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PREANALYTIX GMBH (CH) · FDA 3005202328 |
| 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. PreAnalytiX GmbH is registered in the United States but was not found in the Canadian register.