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.
Devices declared under this manufacturer
- Bobotic Forte
- LACRIMAL
- Simetigast Forte
- Simetigast Forte Baby
- Xylogel hydro
Catalogue references include ALFR-0400-000, LTDR-0500-000, WBOB-0200-000, WTIG-0100-000, WTIG-0128-800, WTIG-0200-000.
European nomenclature codes declared: G0401, Q0399, Q02030206.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| 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 | 9 |
|---|---|
| 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. Zakłady Farmaceutyczne Polpharma SA was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1503348 1 | amended | 2029-07-17 |