Fresenius Kabi AG
DE-MF-000009273 · Germany · Bad Homburg
Fresenius Kabi AG is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 60 |
|---|---|
| Class IIb | 1 |
Among these devices, 59 are declared sterile, 1 with a measuring function.
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 | FRESENIUS KABI AB (SE) · FDA 3002631703 |
| Devices in EUDAMED | 61 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 037258 0014 | supplemented | 2026-10-17 |