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EUDAMED last updated this device on Feb 11, 2026
5713915MS001SZMicroSight® MSI 1-Step HRM Analysis is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by PentaBase A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
057139150004417201(01)05713915000441
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01060214COLORECTAL CANCER (MSI-H / DMMR)3 warnings recorded — scroll inside the panel to see all entries.
The buffers, primer/probe, and tubes are not to be reused
MicroSight® MSI 1-step HRM Analysis can only be run on a BaseTyper™ 48.4, a Gentier or a MyGo PCR RealTime PCR System
DK-MF-000023157The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Denmark; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | — | Still on market |
| Türkiye | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.B-5713915CD005LJAEOn the marketEpiDirect® MGMT Methylation qPCR Assay5713915ED001LYOn 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 marketNo certificate specifically references this device's Basic UDI-DI.