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Accu-Chek

by Roche Diabetes Care GmbH EUDAMED

Active European Union

Ref 07400918057

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04015630070732 Basic UDI-DIDate25 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Accu-Chek Guide Kit mmol/L FC
Model / Reference
07400918057
Primary DI / UDI-DI
04015630070732
Basic UDI-DI
B-04015630070732
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

  • 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