Bioncise NV
BE-MF-000000875 · Belgium · Wellen
Bioncise NV is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 27 |
|---|
Most frequent device types declared: SS‐08‐10.
Among these devices, 9 are declared sterile.
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 | BIONCISE NV (BE) · FDA 3007513241 |
| Devices in EUDAMED | 27 |
| Country of registration | Belgium |