BIOSTER, a.s.
CZ-MF-000011615 · Czechia · Veverská Bítýška
BIOSTER, a.s. is registered in the European database on medical devices as a manufacturer, with 189 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 180 |
|---|---|
| Class IIa | 9 |
Most frequent device types declared: Traumacel PULVIS, 1g, Traumacel PULVIS, 2g, Traumacel PULVIS, 3g, Traumacel PULVIS, 5g, Traumastem P, 1g.
Among these devices, 183 are declared sterile.
Devices declared under this manufacturer
- Celstat
- EMOXICEL FAM Trium
- EMOXICEL TAF RETILIGHT
- IZOTERMICKÁ FÓLIE
- Traumacel FAM OcW
- Traumacel FAM Strata
- Traumacel PULVIS
- Traumacel TAF
- Traumacel TAF Light
- Traumastem FAM Strata
- Traumastem Non-Woven
- Traumastem POWDER
Showing 12 of 189 declared devices.
Catalogue references include 10056, 10232, 10233, 60022, 60114, 60157.
European nomenclature codes declared: M040501, T030399, M03050202, W0202029085.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 189 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 162 |
|---|---|
| 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. BIOSTER, a.s. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
24 0146 TD/NB | issued | 2029-04-28 |
24 0145 QR/NB | issued | 2029-04-28 |