DIAGNOSIS S.A.
PL-MF-000014187 · Poland · BIAŁYSTOK
DIAGNOSIS S.A. 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 | 5 |
|---|
Most frequent device types declared: BP-200U, Cassette pregnancy test, Sensitivity: 10 mIU/ml, DUO pregnancy test, sensitivity: 10 mIU/ml, ISTEL ECG, ISTEL HR-2000.
Among these devices, 2 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- ISTEL ECG
- ISTEL HR-2000
- MANKIET ROZMIAR UNIWERSALNY M/L (22-42 CM)
- Optilet Mini nakłuwacz
- Optilet PRO nakłuwacz
- Test ciążowy DUO Sanovia
- Test ciążowy płytkowy Sanovia
- Test ciążowy strumieniowy Sanovia
Catalogue references include 0020W, 0032W, 0033W, 5144, 5221, 5222.
European nomenclature codes declared: W0102160302, A018099, Z12050301, Z1203020501, Z12050392.
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. DIAGNOSIS S.A. was not found in either the U.S. or the Canadian register.