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FreeStyle Libre 3 Continuous Glucose Monitoring System

by Abbott Diabetes Care Ltd EUDAMED

Active European Union

Ref 72113-01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5021791FLR0003DQ Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
FreeStyle Libre 3 Continuous Glucose Monitoring System (Reader Kit)
Model / Reference
72113-01
Primary DI / UDI-DI
05021791006137
Basic UDI-DI
5021791FLR0003DQ
Direct Marketing DI
05021791006922
EMDN Code
Z1204011501 Non invasive blood sugar monitoring systems
Device Class
Class IIb
Market of Registration
Finland

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

  • 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