EmergoPharm Spółka z ograniczoną odpowiedzialnością Sp. K.
PL-MF-000007178 · Poland · Warszawa
EmergoPharm Spółka z ograniczoną odpowiedzialnością Sp. K. is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 30 |
|---|---|
| Class IIa | 4 |
Most frequent device types declared: 10 ml, 30 ml.
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 | 34 |
| 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 |
|---|---|---|
TNP/MDR/0060/5756/2026 | issued | 2031-05-18 |
TNP/MDR/0054/5756/2026 | supplemented | 2031-05-18 |