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: 000100, 000200, 000300, 002400, 002700.
Among these devices, 25 are declared sterile, 2 active.
Devices declared under this manufacturer
- Algilock Perforiert OK / PS 4
- Algilock Perforiert UK / PI 3
- Algilock UK / BI 2A
- Algilock UK / BI 5
- Bio Miratray OK, S1, 50er
- Bio Miratray OK, S2, 50er
- Fit Kofferdam Kinder Klammer 55
- Fit Kofferdam Kinder Klammer 85
- Fit Kofferdam Molar Klammer, links (P1)
- Mirabrush gelb/spitz
- Mirafluor-Tray large
- Miratray Implant Intro-Kit
Showing 12 of 294 declared devices.
Catalogue references include 101011, 101033, 101037, 101250, 605460, 605622.
European nomenclature codes declared: Q0199, Q010503, Q010207, Q010599, Q019006, Q019001.
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 |
Device-level evidence
| Devices with a numeric GTIN | 294 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. Hager & Werken GmbH & Co. KG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1011605-1 | issued | 2031-05-21 |