ROKO SP. Z O.O.
PL-MF-000050171 · Poland · CZĘSTOCHOWA
ROKO SP. Z O.O. is registered in the European database on medical devices as a manufacturer, with 127 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 127 |
|---|
Devices declared under this manufacturer
- Acron AKM
- Biocetal A2L
- Biocetal A2S
- Biocetal A3 500g
- Biocetal A4M
- Biocetal B1M
- Biocetal B3S
- Biocetal C2 500g
- Biocetal C2S
- Biocetal C3 500g
- Biocetal R2 500g
- Dentiflex DCM
Showing 12 of 127 declared devices.
Catalogue references include AKM, BA2S, BA3 500, BB3S, BC2 500, BC3 500.
European nomenclature codes declared: Q010699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 127 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 127 |
|---|---|
| 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. ROKO SP. Z O.O. was not found in either the U.S. or the Canadian register.