Onera B.V.
NL-MF-000023811 · Netherlands · Eindhoven
Onera B.V. is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: Onera STS I, ONERA STS I.
Among these devices, 14 are declared 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 | ONERA B.V. (NL) · FDA 3026753386 |
| Devices in EUDAMED | 14 |
| Country of registration | Netherlands |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE26/00000233 | issued | 2031-07-27 |