Data / Medical devices / Belgium / Clouds of Care NV
Clouds of Care NV: FDA-registered device maker in Ghent Oost-Vlaanderen, Belgium, 2 510(k) clearances
Clouds of Care NV is registered with the FDA (registration 3014291198) in Ghent Oost-Vlaanderen, Belgium. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014291198
- Address
- Kliniekstraat 27a, Ghent Oost-Vlaanderen, Belgium, 9050
- Owner or operator
- Clouds of Care NV (10056995)
- Roles
- Manufacturer
- First device listed
- February 7, 2018
- Registered through
- 2026
- Brand names listed
- Persyst ESI powered by Epilog, PreOp, PreOp v3
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Source Localization Software For Electroencephalograph Or Magnetoencephalograph | OLX | 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 |
|---|---|---|---|---|---|---|
| February 13, 2026 | K252565 | PreOp v3 | OLX | Substantially Equivalent | Clouds of Care | accessdata.fda.gov |
| January 8, 2018 | K172858 | PreOp | OLX | Substantially Equivalent | Epilog | accessdata.fda.gov |
Compare with other makers
Updated February 13, 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.