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Accu-Chek Guide

by Roche Diabetes Care GmbH Germany EUDAMED

Ref 08116113370

EMDN Z1204011502

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08116113370HH Basic UDI-DIDate25 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Accu-Chek Guide Link mmol/L Kit
Model / Reference
08116113370
Primary DI / UDI-DI
D-08116113370HH
Basic UDI-DI
B-08116113370HH
EMDN Code
Z1204011502 Invasive blood sugar monitoring systems
Device Class
Class IVD Annex II List B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006276

Other devices from Roche Diabetes Care GmbH

See all devices from Roche Diabetes Care GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 3e7a6872-c89e-4dc9-90fd-ef9c80d98323 61 fields · synced 24 Oct 2026