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: Haemorrhoid probes, Rafaelo, 9F, 8F, 6F.
Among these devices, 11 are declared sterile, 17 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0025 | issued | 2030-01-27 |