Manufacturer
Biocartis
BelgiumLegal entities : Biocartis NV
Markets : Belgium · France · Italy · Malta · Poland · Spain · United States
Approvals : EU – class A · United States (FDA) – 510(k) : 1 · PMA : 1 · class II, III · latest in 2025 · see on the FDA website
Public contracts won : Poland 5 · Italy 2 · France 1 · Malta 1 · Spain 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 |
|---|---|---|---|---|
| Nucleic acid testing instruments except micro-arrays - software accessories | W02050182 | A IVDR | EUDAMED record Report an error | |
| Nucleic acid testing integrated extraction /amplification /detection systems | W02050116 | A IVDR | EUDAMED record Report an error |
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