Hager & Werken GmbH & Co. KG
DE-MF-000004938 · Germany · Duisburg
Hager & Werken GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 294 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 292 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: 002400, 000200, 000100, 002800, 002700.
Among these devices, 25 are declared sterile, 2 active.
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 | HAGER & WERKEN GMBH (DE) · FDA 3003487388 |
| Devices in EUDAMED | 294 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1011605-1 | issued | 2031-05-21 |