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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

GlucoMen areo — IVDD — Annex II List B IVDD

MD Atlas
A. MENARINI Diagnostics S.r.l.

EUDAMED last updated this device on May 28, 2026

GlucoMen areo

B-8012992BGMSMgluD8NK

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: A. MENARINI Diagnostics S.r.l.
UDI-DI code: D-8012992BGMSMgluD8NK
Reference / catalog number: 46203, 46211,46210, 46213, 49261, 48742, 46214, 46215, 46212

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View device family (Basic UDI)

Manufacturer information

Organization name: A. MENARINI Diagnostics S.r.l.
SRN: IT-MF-000023427
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Jul 28, 2014	Dec 31, 2027

Device identification

Trade name: GlucoMen areo
UDI-DI code: D-8012992BGMSMgluD8NK
Basic UDI-DI: B-8012992BGMSMgluD8NK
Reference / catalog number: 46203, 46211,46210, 46213, 49261, 48742, 46214, 46215, 46212
Issuing entity: EUDAMED

Classification

Risk category: IVDD — Annex II List B
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Your GlucoMen® areo meter and GlucoMen® areo Sensor are in vitro diagnostic medical devices to quantitatively measure the glucose level in fresh capillary whole blood. They are intended for self testing to monitor and control blood glucose levels by people with diabetes mellitus; they can also be used in a clinical setting by healthcare professionals. They are not intended for diagnosis or screening of diabetes or for neonatal use. Do not alter your treatment on the basis of test results of this meter without previously consulting your doctor or healthcare professional.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-8012992BGMSMgluD8NK

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0101060101GLUCOSE TEST STRIPS
W010106010801BLOOD TEST STRIPS CONTROLS
W0201060102BLOOD GLUCOSE METERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Certificates

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.