AssisTech Sp. z o.o.
PL-MF-000002848 · Poland · Gdańsk
AssisTech Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: Mobile Stand.
Among these devices, 4 are declared active.
Devices declared under this manufacturer
- BASIC 1.0
- BASIC 2.0
- BASIC 3.0
- C-Eye
- C-Eye II
- NeuroTAB
- PRO 2.0
- eyeTAB
Catalogue references include BASIC 1.0, C-Eye, C-Eye II, MS, NeuroTAB, PRO 2.0.
European nomenclature codes declared: Y99.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 8 |
|---|---|
| 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. AssisTech Sp. z o.o. was not found in either the U.S. or the Canadian register.