Carnamedica Sp. z o.o.
PL-MF-000017531 · Poland · Warszawa
Carnamedica Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 16 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: LungProtect® capacity 1000 mL, StoreProtect Plus® capacity 2000 mL, PumpProtect® capacity 2000 mL, Belzer MPS® (UW Machine Perfusion Solution) capacity 2000 mL, Cannula for organ perfusion 25F-K-B.
Among these devices, 18 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 | Registered with FDA |
|---|---|
| Matched entry | CARNAMEDICA SP Z O O (PL) · FDA 3017223202 |
| Devices in EUDAMED | 18 |
| Country of registration | Poland |