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EUDAMED last updated this device on Feb 11, 2026
5713915MS001SZDK-MF-0000231573 warnings recorded — scroll inside the panel to see all entries.
CW266CW009CW036Primary placement in Denmark; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Still on market | |
| Türkiye | Still on market |
W01060214COLORECTAL CANCER (MSI-H / DMMR)No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.5713915ED001LYOn the marketEpiDirect® MLH1 Methylation qPCR Assay5713915ED002M2On the marketPlentiPlex™ KIT Mastocytosis qPCR Assay5713915PP001TDOn the marketPlentiPlex™ KIT Mastocytosis qPCR Assay5713915PP001TDOn the marketPlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay5713915PP004TKOn the market