- Role
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- Date of registration
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IT-MF-000023427V10305320020GlucoMen areo Control is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by A. MENARINI Diagnostics S.r.l.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 9, 2026
B-8012992BGMSCgluB2HXPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-8012992BGMSCgluB2HX
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 Germany; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jan 8, 2015 | Dec 31, 2027 |
| Austria | Jan 8, 2015 | Dec 31, 2027 |
| Belgium | Jan 8, 2015 | Dec 31, 2027 |
| Denmark | Jan 8, 2015 | Dec 31, 2027 |
| EL | Jan 8, 2015 | Dec 31, 2027 |
| Spain | Dec 14, 2017 | Dec 31, 2027 |
| Finland | Jan 8, 2015 | Dec 31, 2027 |
| Italy | May 11, 2018 | Dec 31, 2027 |
| Luxembourg | Jan 8, 2015 | Dec 31, 2027 |
| Norway | Jan 8, 2015 | Dec 31, 2027 |
| Portugal | Mar 20, 2017 | Dec 31, 2027 |
| Sweden | Jan 8, 2015 | Dec 31, 2027 |
| XI | Jan 8, 2015 | Dec 31, 2027 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-8012992BGMSCgluB2HXBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-8012992BGMSCgluB2HX46197,46199,46201,47954,46198,46200,46202,47955UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W010106010801BLOOD TEST STRIPS CONTROLSNo certificate specifically references this device's Basic UDI-DI.
B-8012992BGMSMgluD8NKOn the marketGlucoMen areo B-Ketone ControlB-8012992BGMSCketAXKUOn the marketGlucoMen areo B-Ketone SensorB-8012992BGMSSketEFRLOn the marketGlucoMen areo GKB-8012992BGMSMgluketUVRWOn the marketGlucoMen areo SensorB-8012992BGMSSgluEJS6On the marketOSMO Wash Solution8012992URIGXOn 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.