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.
Devices declared under this manufacturer
- Spirotome
- Spirotome Bone
- Spirotome Endo
- Spirotome SS‐08-MR
- Spirotome SS‐08‐08
- Spirotome SS‐08‐20
- Spirotome SS‐08‐MR
- Spirotome SS‐10‐06
- Spirotome SS‐10‐15
- Spirotome SS‐14‐08
- Spirotome SS‐14‐10
- Spirotome SS‐14‐15
Showing 12 of 27 declared devices.
Catalogue references include 05407005001042, 05407005001073, 05407005001103, 05407005001165, 05407005001295, SS-08-CE.
European nomenclature codes declared: A0102010101, A01020199, A01020501, A010299.
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 |
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| Found in the U.S. device database | 25 |
| Share | 92.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIONCISE NV |
North American profile: Both markets. Bioncise NV is registered in both the United States and Canada.