Ursatec GmbH
DE-MF-000005353 · Germany · Tholey
Ursatec GmbH is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Most frequent device types declared: HSNS01, ISNSD01, ISNSE01, HNST01, ISNS01.
Among these devices, 1 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 | URSATEC GMBH (DE) · FDA 3015789003 |
| Devices in EUDAMED | 31 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ECM23MDR002 | issued | 2028-08-01 |