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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

GLUCOFIX TECH — IVDD — Annex II List B IVDD

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

EUDAMED last updated this device on May 28, 2026

GLUCOFIX TECH

B-8012992BGMSMgluD82G6

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-8012992BGMSMgluD82G6
Reference / catalog number: 46639 , 46634, 46635, 46636, 46637, 49573, 51344

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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 Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Mar 31, 2015	Dec 31, 2027

Device identification

Trade name: GLUCOFIX TECH
UDI-DI code: D-8012992BGMSMgluD82G6
Basic UDI-DI: B-8012992BGMSMgluD82G6
Reference / catalog number: 46639 , 46634, 46635, 46636, 46637, 49573, 51344
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: Uw GLUCOFIX® TECH meter en GLUCOFIX® TECH Sensor teststrips zijn medische hulpmiddelen voor in-vitro diagnostiek die dienen voor de kwantitatieve meting van glucose in vers capillair volbloed. Zij zijn bestemd voor zelftesten bij het onder controle houden van bloedglucosewaarden bij mensen met diabetes mellitus. Zij zijn niet bedoeld voor het diagnosticeren of screenen van diabetes, of voor gebruik bij pasgeborenen. Verander uw behandeling niet op basis van testresultaten met deze meter zonder eerst uw arts of professionele zorgverlener te hebben geraadpleegd.
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-8012992BGMSMgluD82G6

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.

W010106010801BLOOD TEST STRIPS CONTROLS
W0101060101GLUCOSE TEST STRIPS
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.