Manufacturer
Fresenius Kabi
GermanyLegal entities : Fresenius Kabi AG
Markets : Austria · Belgium · Czechia · Denmark · Finland · France · Germany · Italy · Luxembourg · Poland · Portugal · Spain · United States
Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 17 · class I, II, III · latest in 2026 · see on the FDA website
Public contracts won : Czechia 47 · Spain 45 · Poland 27 · Italy 24 · Germany 13 · France 7 · Finland 6 · Austria 4 · Belgium 4 · Portugal 4 · Denmark 1 · Luxembourg 1
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Blood transfusion instruments - hardware accessories | Z121780 | IIa, IIb MDR | EUDAMED record Report an error | |
| Infusion instruments - software accessories | Z12030382 | I, IIb MDR | EUDAMED record Report an error | |
| Blood transfer bags and kits - other | B010299 | IIb MDR | EUDAMED record Report an error | |
| Infusion instruments - medical device software | Z12030392 |
|
I MDR | EUDAMED record Report an error |
| Infusion pumps | Z12030301 |
|
IIb MDR | EUDAMED record Report an error |
| Syringe pumps | Z12030302 |
|
IIb MDR | EUDAMED record Report an error |
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