Zakłady Farmaceutyczne Polpharma SA
PL-MF-000010601 · Poland · Starogard Gdański
Zakłady Farmaceutyczne Polpharma SA is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 5 |
|---|---|
| Class IIb | 3 |
| Class IIa | 1 |
Among these devices, 1 are declared sterile.
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 | 9 |
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1503348 1 | amended | 2029-07-17 |