Data / Medical devices / Belgium / Qompium NV
Qompium NV: FDA-registered device maker in Hasselt Limburg, Belgium, 1 510(k) clearance
Qompium NV is registered with the FDA (registration 3015976873) in Hasselt Limburg, Belgium. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015976873
- Address
- Kempische Steenweg 303/27, Hasselt Limburg, Belgium, 3500
- Owner or operator
- Qompium NV (10061438)
- Roles
- Manufacturer
- First device listed
- July 26, 2024
- Registered through
- 2026
- Brand names listed
- FibriCheck
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | QME | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 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 |
|---|---|---|---|---|---|---|
| June 7, 2024 | K232804 | FibriCheck | QME | Substantially Equivalent | Qompium NV | accessdata.fda.gov |
Compare with other makers
- All makers of Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
Updated June 7, 2024. 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.