Data / Medical devices / Netherlands / Onera B.V.
Onera B.V.: FDA-registered device maker in Eindhoven Noord-Brabant, Netherlands, 4 510(k) clearances
Onera B.V. is registered with the FDA (registration 3026753386) in Eindhoven Noord-Brabant, Netherlands. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026753386
- Address
- Torenallee 42-54, Eindhoven Noord-Brabant, Netherlands, 5617BD
- Owner or operator
- Onera B.V. (10087157)
- Roles
- Manufacturer
- First device listed
- January 19, 2023
- Registered through
- 2026
- Brand names listed
- Onera STS, Onera STS 2, Onera Sleep Test System 2, Onera SleepMap
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 2 | Manufacturer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 8, 2026 | K253668 | Onera SleepMap (SLEEPMAP) | OLZ | Substantially Equivalent | Onera B.V. | accessdata.fda.gov |
| July 3, 2025 | K243220 | Onera STS 2 (ONERA STS 2) | MNR | Substantially Equivalent | Onera B.V. | accessdata.fda.gov |
| August 18, 2023 | K223573 | Onera Sleep Test System (Onera STS) | MNR | Substantially Equivalent | Onera B.V. | accessdata.fda.gov |
| April 6, 2022 | K210593 | Onera Sleep Test System (Onera STS) | MNR | Substantially Equivalent | Onera B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Ventilatory Effort Recorder
Updated March 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.