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FreeStyle Libre 2 Flash Glucose Monitoring System

by Abbott Diabetes Care Ltd 25 variants

Ref 71972-01, 71956-01, 71994-01, 79088-01

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5021791FLR0002DN Basic UDI-DI Date23 Apr 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
FreeStyle Libre 2 Flash Glucose Monitoring System
Libre
Device Name
FreeStyle Libre 2 Flash Glucose Monitoring System (Reader Kit)
Libre App
Model / Reference
71972-01, 71956-01, 71994-01, 79088-01
Primary DI / UDI-DI
05021791006069, 05021791001392, 05021791001033, 05021791010554
Basic UDI-DI
5021791FLR0002DN, 5021791FLS0002DZ, 5021791LAP0001BM
Direct Marketing DI
05021791006199
05021791006502
EMDN Code
Z1204011501, Z1204011585
Device Class
Class IIb
Special Device Type
Software
EU market of registration
Croatia
Belgium
Spain
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

  • Sterile NoEUDAMEDYesEUDAMED
  • Measuring Function

Other properties (11)

  • 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