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EUDAMED last updated this device on Nov 5, 2025
++B7149000122R9000-12 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Diagnostics for the Real World Ltd. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
B71490001209000-12B7149000120
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090699OTHER MULTIPLE PATHOGENS - RT & POC3 warnings recorded — scroll inside the panel to see all entries.
Primary placement in XI; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| XIPrimary placement | Nov 30, 2025 | Still on market |
US-MF-000023951ITDA/00003/0 v002Sterile
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 →This device is not currently linked to any other device.
Certificate health across this manufacturer's portfolio.
ITDA/00003/0 v002AmendedIQMS/00004/0 v001IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →