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
| other | 52 |
|---|---|
| Class IIa | 1 |
Most frequent device types declared: QIAstat-Dx Analyzer.
Among these devices, 6 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1782924-1 | supplemented | 2026-06-29 |
HX 1782924-1 | reissued | 2031-06-29 |