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EUDAMED last updated this device on Jun 10, 2026
5430003908GeneFoxCubVEGeneFoxCub is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by LaCAR MDx Technologies. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05430004910121GeneFoxCubBE-MF-000001212(01)05430004910121
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.
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.
Primary placement in Belgium; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Jul 26, 2024 | Still on market |
| Germany | Jul 26, 2024 | Still on market |
| Spain | Jul 26, 2024 | Still on market |
| Italy | Jul 26, 2024 | Still on market |
| Lithuania | Jul 26, 2024 | Still on market |
| Latvia | Jul 26, 2024 | Still on market |
| Romania | Jul 26, 2024 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02079092VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWAREPrimary 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 →B-05430002471785On the marketNEONATAL TSH Screening ELISAB-05430002471778On the marketNEONATAL PAP Screening ELISAB-05430002471709On the marketLAMP Human CYP2C9 deficiency KITB-05430002471228On the marketLAMP Human DPD deficiency KIT - 4 mutationsB-05430002471167On the marketLAMP Human DPD deficiency KIT - 4 mutationsB-05430002471150On the marketNo certificate specifically references this device's Basic UDI-DI.
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.