Fysicon B.V.
NL-MF-000002694 · Netherlands · Oss
Fysicon B.V. is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 87 |
|---|---|
| Class IIb | 5 |
Most frequent device types declared: DataLinQ USG, DataLinQ CRM, DataLinQ RDM, DataLinQ 2PAD, EVOCS.
Among these devices, 10 are declared active, 5 with a measuring function.
Devices declared under this manufacturer
- ACIST FFR Connection Kit
- BOSTON FFR Connection Kit
- IBP Cable Medex Logical – Prucka (320CM)
- IR, 5-Lead, AHA, Basic Monitoring Kit
- QMAPP 10 Lead ECG Trunk cable, AHA, 320 CM
- QMAPP 10 Lead ECG Trunk cable, IEC 320 CM
- QMAPP 5 Lead ECG Trunk cable, AHA 320 CM
- QMAPP AUX cable to 6.3 mm Mono Jack for Volcano i5, Black 165 CM
- QMAPP AUX to BNC cable
- QMAPP GO
- QMAPP System Cable blue for QMAPP Hybrid (2500cm)
- Temperature Connection cable to SM level 1 400 Acoustascope
Showing 12 of 92 declared devices.
Catalogue references include 01076108, 01076110, 01076153, 01076157, 01077006, 01503002.
European nomenclature codes declared: Z12050785, Z12050702, Z12059099, Z12059092, Z110603.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 92 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 92 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Fysicon B.V. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
24M00192CRT01 | reissued | 2030-03-14 |
24M00192CRT01 | reissued | 2030-03-14 |
21M00066CRT02 | amended | 2025-03-14 |