GlucoMen areo B-Ketone Sensor

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref 48106,48105,49245,48103,48688,48101,47953,47951,47952,48703,48820,48821,48530,48531

by A. MENARINI Diagnostics S.r.l.

Identity

Trade Name: GlucoMen areo B-Ketone Sensor EUDAMED
Device Name: GlucoMen areo B-Ketone Sensor EUDAMED
Model / Reference: 48106,48105,49245,48103,48688,48101,47953,47951,47952,48703,48820,48821,48530,48531 EUDAMED

Identifiers

Primary DI / UDI-DI: D-8012992BGMSSketEFRL EUDAMED
Basic UDI-DI: B-8012992BGMSSketEFRL EUDAMED
EMDN Code: W0101060110 KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) EUDAMED

Classification

Device Class: Class IVD devices for self-testing EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

Yes

EUDAMED

GlucoMen areo B-Ketone Sensor by A. MENARINI Diagnostics S.r.l. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-8012992BGMSSketEFRL	Class IVD devices for self-testing	Active

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Manufacturer

Manufacturer: A. MENARINI Diagnostics S.r.l.
EUDAMED SRN: IT-MF-000023427

Sources (2)

EUDAMED d958b717-1283-4ad7-acb3-220a0cef2a0b-1 61 fields · synced Jul 9, 2026
EUDAMED d958b717-1283-4ad7-acb3-220a0cef2a0b-2 61 fields · synced Jul 9, 2026