EPflex Feinwerktechnik GmbH
DE-MF-000005425 · Germany · Dettingen an der Erms
EPflex Feinwerktechnik GmbH is registered in the European database on medical devices as a manufacturer, with 322 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 232 |
|---|---|
| Class I | 90 |
Among these devices, 321 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 | EPFLEX FEINWERKTECHNIK GMBH (DE) · FDA 3003289691 |
| Devices in EUDAMED | 322 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000266008 | issued | 2029-07-02 |
1000265993 | issued | 2028-11-08 |