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: Belzer MPS® (UW Machine Perfusion Solution) capacity 2000 mL, Belzer UW® Cold Storage Solution (University of Wisconsin Solution) ca, Cannula for organ perfusion 25F-K-B, CelProtect® capacity 2000 mL, LungProtect® capacity 1000 mL.
Among these devices, 18 are declared sterile.
Devices declared under this manufacturer
- Belzer MPS® (UW Machine Perfusion Solution)
- Belzer UW® Cold Storage Solution (University of Wisconsin Solution)
- Cannula for organ perfusion - Back table adapter
- Cannula for organ perfusion 25F-K-B
- CelProtect®
- LungProtect®
- PlegiStore®
- PumpProtect®
- StoreProtect Plus®
- StoreProtect®
Showing 12 of 18 declared devices.
Catalogue references include BMPSC2000, BUWC, KP25-34-K-B, LPRT, PLST, PLST2000.
European nomenclature codes declared: C0399.
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 |
Device-level evidence
| Devices with a numeric GTIN | 18 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 11.1 % |
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: United States only. Carnamedica Sp. z o.o. is registered in the United States but was not found in the Canadian register.