Data / Medical devices / Netherlands / Fysicon BV
Fysicon BV: FDA-registered device maker in Oss Noord-Brabant, Netherlands, 2 510(k) clearances
Fysicon BV is registered with the FDA (registration 3010716438) in Oss Noord-Brabant, Netherlands. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010716438
- Address
- Hoogheuvelstraat 114, Oss Noord-Brabant, Netherlands, 5349BA
- Owner or operator
- Fysicon BV (10047296)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- August 4, 2014
- Registered through
- 2026
- Brand names listed
- DataLinQ (DatalinQ 2 PAD, DataLinQ ATR, DataLinQ CRM as components) DataLinQ USG, QMAPP #01076001, QMAPP Connection Box # 01076094, QMAPP EP #01076102, QMAPP GO #01076110, QMAPP Hemo #01076101, QMAPP Hemo Lite #01076103, QMAPP Hybrid # 01076106 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| August 27, 2025 | K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | MWI | Substantially Equivalent | Fysicon BV | accessdata.fda.gov |
| September 8, 2017 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP | MWI | Substantially Equivalent | Fysicon BV | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Medical Device Data System
Updated August 27, 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.