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FreeStyle Libre 2 Flash Glucose Monitoring System

by Abbott Diabetes Care Ltd 25 variants

Ref 71988-01

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

Recall on shared 510(k) K193371; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222447↗

+2 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5021791FLS0002DZ Basic UDI-DI 05021791000876UDI-DIDate5 May 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK222447 Date3 Mar 2023IssuedStatusActive

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.

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2414-2023 FDA Class II initiated 12 Jul 2023 on shared 510(k) K193371

    If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

    • Ongoing Z-1275-2023 FDA Class I initiated 13 Feb 2023 on shared 510(k) K193371

    Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

    • Ongoing Z-1931-2021 FDA Class II initiated 16 Mar 2021 on shared 510(k) K193371

    Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
71988-01
Primary DI / UDI-DI
05021791000876
Basic UDI-DI
5021791FLS0002DZ
EMDN Code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

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

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a factory-calibrated, integrated continuous glucose monitoring device designed to provide real-time glucose readings without the need for routine fingerstick calibration. It employs a subcutaneous sensor to measure interstitial glucose levels, transmitting data wirelessly to a companion reader or smartphone app for continuous monitoring and trend analysis.

The system is supplied as a sterile, single-use device intended for outpatient use in diabetes management. Each sensor kit includes a reusable reader or app-enabled smartphone for data reception, with no implantable or reusable components. The device operates independently of MRI environments and is available in standardized sensor sizes. Regulatory authorisations include FDA 510(k) clearance and MDR compliance, with UDI identifiers ensuring traceability.

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Properties

  • Sterile
  • 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