ORGENTEC Diagnostika GmbH
DE-MF-000033178 · Germany · Mainz
ORGENTEC Diagnostika GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| other | 6 |
|---|
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 | ORGENTEC DIAGNOSTIKA GMBH (DE) · FDA 3003232042 |
| Devices in EUDAMED | 6 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V13 120500 0004 | issued | 2031-08-10 |