Manufacturer
Phadia
SwedenLegal entities : Phadia AB
Markets : Czechia · Sweden · United States
Approvals : EU – class A, B · United States (FDA) – 510(k) : 56 · class I, II · latest in 2026 · see on the FDA website
Public contracts won : Czechia 7
- 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 |
|---|---|---|---|---|
| Automated immunochemistry analysers - IVD medical device software | W0201020192 | A, B IVDR | EUDAMED record Report an error | |
| Automated immunochemistry analysers - hardware accessories | W0201020180 | A IVDR | EUDAMED record Report an error | |
| Automated immunochemistry analysers - low routine (throughput <= 100 test/h) | W0201020101 |
|
A IVDR | EUDAMED record Report an error |
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