Gofarm Sp. z o.o. Sp. k.
PL-MF-000003485 · Poland · Kraków
Gofarm Sp. z o.o. Sp. k. is registered in the European database on medical devices as a manufacturer, with 141 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 140 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: 30 ml, 15 ml, 100 ml, 50 ml, 20g,15g.
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 | 141 |
| 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 |
|---|---|---|
1434-MDR-046/2025 | issued | 2030-12-15 |
1434-MDR-045/2025 | issued | 2030-12-11 |
1434-MDR-044/2025 | issued | 2030-11-12 |
1434-MDR-042/2025 | issued | 2030-11-05 |
1434-MDR-041/2025 | supplemented | 2030-11-05 |
1434-MDR-030/2025 | issued | 2030-09-24 |
1434-MDR-014/2025 | supplemented | 2030-06-22 |
1434-MDR-006/2026 | issued | 2031-03-31 |