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GLUCOFIX TECH B-Ketone Control

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref 48591 (IT/FR/NL), 48592 (IT/FR/NL), 61555 (UK), 61556 (UK)

by A. MENARINI Diagnostics S.r.l.

Identity

Trade Name
GLUCOFIX TECH B-Ketone Control EUDAMED
Device Name
GLUCOFIX TECH B-Ketone Control EUDAMED
Model / Reference
48591 (IT/FR/NL), 48592 (IT/FR/NL), 61555 (UK), 61556 (UK) EUDAMED

Identifiers

Primary DI / UDI-DI
D-8012992BGMSCketAX2CA EUDAMED
Basic UDI-DI
B-8012992BGMSCketAX2CA EUDAMED
EMDN Code
W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED

Classification

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

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

GLUCOFIX TECH B-Ketone Control 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

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Manufacturer

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

Sources (2)

  • EUDAMED b8a1013f-cd8c-4c47-b98c-40993375c05f-1 61 fields · synced Jun 18, 2026
  • EUDAMED b8a1013f-cd8c-4c47-b98c-40993375c05f-2 61 fields · synced Jun 18, 2026