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.
Catalogue references include ONERA STS I CHEST, ONERA STS I FLOW, ONERA STS I FLOW ADHESIVE, ONERA STS I FLOW CRADLE, ONERA STS I LEG, ONERA STS I LEG ADHESIVE.
European nomenclature codes declared: Z12100501.
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 |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Onera B.V. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE26/00000233 | issued | 2031-07-27 |