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GlucoLeader Enhance 2 Blood Glucose Monitoring System

by HMD Biomedical Inc.

Ref 3K-01-250081 / 3K-01-250082Model Enhance 2

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04711200722109 Basic UDI-DI 04711200722109UDI-DIDate18 Apr 2025RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
GlucoLeader
Model / Reference
Enhance 2, 3K-01-250081 / 3K-01-250082
Primary DI / UDI-DI
04711200722109
Basic UDI-DI
B-04711200722109
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class IVD Annex II List B

Manufacturer details

EUDAMED SRN
TW-MF-000032809
Authorised representative
Luana Med. B.V. NL-AR-000002750

Other devices from Hmd Biomedical Inc.

See all devices from Hmd Biomedical Inc. →

Properties

  • Self Testing
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Companion Diagnostics: No