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EUDAMED last updated this device on May 25, 2022
B-5713915CD005LJAEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →8177, 8180 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by PentaBase A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →D-5713915CD005LJAEBasic 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 →B-5713915CD005LJAE8177, 8180UDI 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 →D-5713915CD005LJAE
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105070503RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS1 warning recorded — scroll inside the panel to see all entries.
CW009Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Denmark; available across 1 country total.
Placed on the market in Denmark; per-country availability dates not published.
DK-MF-000023157No 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-5713915CD002LC9HOn the market8015, 8010, 8079B-5713915CD001LA98On the market8213, 8214B-5713915CD003LE9SOn the marketEpiDirect® MGMT Methylation qPCR Assay5713915ED001LYOn the marketEpiDirect® MLH1 Methylation qPCR Assay5713915ED002M2On the marketMicroSight® MSI 1-Step HRM Analysis5713915MS001SZOn the market