FUJIFILM medwork GmbH
DE-MF-000008444 · Germany · Höchstadt a.d. Aisch
FUJIFILM medwork GmbH is registered in the European database on medical devices as a manufacturer, with 251 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 137 |
|---|---|
| Class IIb | 114 |
Most frequent device types declared: INJ1-A1-05-5-18-180, BIO1-C4-18-120, LIT1-C3-25-23-200, LIT1-C3-30-23-200, FOR1-N1-30-220.
Among these devices, 233 are declared sterile, 114 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 | FUJIFILM medwork GmbH (DE) · FDA 3020707080 |
| Devices in EUDAMED | 251 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000297126 | supplemented | 2028-10-01 |