Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.
PL-MF-000009264 · Poland · Wrocław
Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 12 |
|---|---|
| Class IIa | 1 |
Devices declared under this manufacturer
- Kebene extra
- Kebene forte
- Salvit Gastricon
- ULGIX USG
- ULGIX WZDĘCIA
- ULGIX WZDĘCIA MAX
- Żel do USG
Showing 12 of 13 declared devices.
Catalogue references include _.
European nomenclature codes declared: G0401, Z11049085.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| 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 | 13 |
|---|---|
| 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. Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1434-MDR-004/2026 | issued | 2031-02-11 |
1434-MDR-003/2026 | issued | 2031-02-11 |
1434-MDR-001/2024 | issued | 2029-02-28 |