GlucoMen areo GK

Organization name

A. MENARINI Diagnostics S.r.l.

SRN

IT-MF-000023427

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 1 country total.

Trade name

GlucoMen areo GK

UDI-DI code

D-8012992BGMSMgluketUVRW

Basic UDI-DI

B-8012992BGMSMgluketUVRW

Reference / catalog number

54524, 52082, 52081, 52083, 61554, 61553,

Issuing entity

EUDAMED

Risk category

IVDD — Annex II List B

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Your GlucoMen® areo GK meter, GlucoMen® areo Sensor, and GlucoMen® areo β-Ketone Sensor are in vitro diagnostic medical devices to quantitatively measure glucose levels in fresh capillary whole blood drawn from fingertips, palm, or forearm, and β-ketone levels in capillary whole blood from fingertips. They are intended for self-testing to monitor and control blood glucose and β-ketone 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 and DKA or for neonatal use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-8012992BGMSMgluketUVRW

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

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

• W0101060101GLUCOSE TEST STRIPS
• W0101060110KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
• W010106010801BLOOD TEST STRIPS CONTROLS
• W020106019099VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER