QIAGEN GmbH
DE-MF-000004949 · Germany · Hilden
QIAGEN GmbH is registered in the European database on medical devices as a manufacturer, with 53 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 |
|---|
Most frequent device types declared: QIAstat-Dx Analyzer.
Among these devices, 6 are declared sterile.
Devices declared under this manufacturer
- Buffer EL
- EZ1 DSP Virus Kit
- EZ2 Connect MDx
- QFT-Plus 2 Plate Kit ELISA
- QFT-Plus HA Single Patient Pack
- QIAamp DSP DNA FFPE Tissue Kit
- QIAcube Connect MDx
- QIAcuityDx Nanoplate 26k 24-well
- QIAsymphony DSP DNA Mini Kit
- QIAsymphony DSP DNA Virus/Pathogen Mini Kit
- QIAsymphony SP
- Rotor-Gene Q MDx 5Plex HRM
Showing 12 of 53 declared devices.
Catalogue references include 60404, 623222, 62724, 9001297, 9002030, 9003070.
European nomenclature codes declared: W0105900101, W02050116, W050101010201, W010699, W02050106, W0580.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | QIAGEN, GMBH (DE) · FDA 3004013603 |
| Devices in EUDAMED | 53 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 53 |
|---|---|
| Found in the U.S. device database | 28 |
| Share | 52.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | QIAGEN GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 4 |
| First licensed | 2014-03-20 |
Licence types: System (2), Test Kit (2).
Licensed under: ROTOR-GENE Q MDX 5PLEX HRM, THERASCREEN KRAS RGQ PCR KIT, QIASTAT-DX ANALYZER 1.0, QIASTAT-DX GASTROINTESTINAL PANEL 2.
North American profile: Both markets. QIAGEN GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1782924-1 | supplemented | 2026-06-29 |
HX 1782924-1 | reissued | 2031-06-29 |