Data / Medical devices / Belgium / Feops NV
Feops NV: FDA-registered device maker in Gent Oost-Vlaanderen, Belgium, 4 510(k) clearances
Feops NV is registered with the FDA (registration 3020703662) in Gent Oost-Vlaanderen, Belgium. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020703662
- Address
- Technologiepark-Zwijnaarde 122, Gent Oost-Vlaanderen, Belgium, 9052
- Owner or operator
- FEops NV (10082838)
- Roles
- Manufacturer
- First device listed
- October 7, 2021
- Registered through
- 2026
- Brand names listed
- FEops HEARTguide, FEops HEARTguide ALPACA, FEops HEARTguide ALPACA 3.3, FEops HEARTguide Simulation Application, FEops HEARTguide Simulation Application v1.4.2, FEops HEARTguide Simulation Application v4.1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Cardiovascular Implant Simulation Software Device | QQI | 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 |
|---|---|---|---|---|---|---|
| November 25, 2025 | K250635 | FEops HEARTguide Simulation Application | QQI | Substantially Equivalent | Feops NV | accessdata.fda.gov |
| June 6, 2023 | K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | QIH | Substantially Equivalent | Feops NV | accessdata.fda.gov |
| February 25, 2022 | K214066 | FEops HEARTguide | QQI | Substantially Equivalent | Feops NV | accessdata.fda.gov |
| September 8, 2021 | DEN200030 | FEops HEARTguide | QQI | Unknown | Feops NV | accessdata.fda.gov |
Compare with other makers
Updated November 25, 2025. 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.