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FreeStyle Libre 3 app

by Abbott Diabetes Care Ltd United Kingdom EUDAMED

Ref 78826-01, 78825-01

EMDN Z1204011501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5021791FLA00037V Basic UDI-DIDate21 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
78826-01, 78825-01
Primary DI / UDI-DI
05021791011728, 05021791011711
Basic UDI-DI
5021791FLA00037V
EMDN Code
Z1204011501 Non invasive blood sugar monitoring systems
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
GB-MF-000029309
Authorised representative
Abbott B.V. NL-AR-000012577

Other devices from Abbott Diabetes Care Ltd

See all devices from Abbott Diabetes Care Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 6dca37b7-ccc7-4000-abd8-b84da7e33421 61 fields · synced 24 Oct 2026
  • EUDAMED 05021791011711|5021791FLA00037V 61 fields · synced 16 May 2026