Manufacturer
Fujirebio
Belgium, JapanLegal entities : Fujirebio Europe N.V., Fujirebio Inc.
Markets : Belgium · France · Italy · United States
Approvals : EU – class A, C · United States (FDA) – 510(k) : 47 · PMA : 1 · class I, II, III · latest in 2025 · see on the FDA website
Public contracts won : Italy 8 · France 2
EU representative : Fujirebio Europe N.V. (Belgium)
- 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 |
|---|---|---|---|---|
| Various general purpose IVD instruments - software accessories | W02079082 | A IVDR | EUDAMED record Report an error | |
| Various general purpose IVD instruments - IVD medical device software | W02079092 | A IVDR | EUDAMED record Report an error | |
| Devices for samples analyses - other | W05039099 | A IVDR | EUDAMED record Report an error | |
| Full genotyping high-risk + low-risk HPV - NA reagents | W0105041004 | C IVDR | EUDAMED record Report an error | |
| Hepatitis b virus - genotyping - NA reagents | W0105020218 | C IVDR | EUDAMED record Report an error | |
| Hepatitis c virus (HCV) genotyping - NA reagents | W0105020309 | C IVDR | EUDAMED record Report an error | |
| Immunochemistry instruments - other | W02010299 | A IVDR | EUDAMED record Report an error | |
| IVD instruments - other | W0299 |
|
A IVDR | EUDAMED record Report an error |
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