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EUDAMED last updated this device on Jun 9, 2026
B-8012992BGMSCketAX2CAGLUCOFIX TECH B-Ketone Control is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by A. MENARINI Diagnostics S.r.l.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-8012992BGMSCketAX2CA48591 (IT/FR/NL), 48592 (IT/FR/NL), 61555 (UK), 61556 (UK)IT-MF-000023427V10305320020D-8012992BGMSCketAX2CA
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 Netherlands; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Sep 14, 2017 | Dec 31, 2027 |
| France | Sep 14, 2017 | Dec 31, 2027 |
| Italy | Sep 14, 2017 | Dec 31, 2027 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W010106010801BLOOD TEST STRIPS CONTROLSPrimary 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 certificate specifically references this device's Basic UDI-DI.
B-8012992BGMSSgluEJ2M4On the marketAution wash solution8012992URIGXOn the marketGLUCOFIX TECHB-8012992BGMSMgluD82G6On the marketGLUCOFIX TECH ControlB-8012992BGMSCgluB229YOn the marketGlucoMen areoB-8012992BGMSMgluD8NKOn the marketGlucoMen areo B-Ketone ControlB-8012992BGMSCketAXKUOn the marketNo 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.