F Care Systems
BE-MF-000000037 · Belgium · Antwerp
F Care Systems is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 14 |
|---|---|
| Class IIa | 4 |
Most frequent device types declared: 6F, 7F, 8F, 9F, CR45i.
Among these devices, 11 are declared sterile, 17 active.
Devices declared under this manufacturer
- EVRF
- Fistura
- HPR45i
- MedRF4000
- Rafaelo
- Rafaeloprobe
- Sphera probe
- ThermaVein
- Veineo
- Viridex RF
Showing 12 of 18 declared devices.
Catalogue references include 00EVRFV2, 00MEDRF4000, 00RAFAELO, 00ThermaVein+, 05FIS6F, 05FIS7F.
European nomenclature codes declared: Z12010905, K02010199, C0190190401, G020499, G02060301.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FCARE SYSTEMS NV (BE) · FDA 3008264458 |
| Devices in EUDAMED | 18 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 18 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 38.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | F CARE SYSTEMS NV |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2024-09-24 |
Licence types: System (1).
Licensed under: F CARE RF SYSTEM.
North American profile: Both markets. F Care Systems is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0025 | issued | 2030-01-27 |