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 |
|---|---|
| other | 3 |
Most frequent device types declared: Optilet PRO, Optilet MINI, ISTEL HR-2000, Cassette pregnancy test, Sensitivity: 10 mIU/ml, Midstream pregnancy test, sensitivity: 10 mIU/ml , BP-200U.
Among these devices, 2 are declared active, 2 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Poland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.