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Blood glucose meter

by Cofoe Medical Technology Co., Ltd. China EUDAMED

Ref KF-B12Model KF-B12, GKF-B01, KF-B06, KF-B07, KF-B09, KF-B10 EMDN W0201060102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69507155KBGMT5 Basic UDI-DIDate1 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
KF-B12, GKF-B01, KF-B06, KF-B07, KF-B09, KF-B10
Primary DI / UDI-DI
06950715571583
Basic UDI-DI
69507155KBGMT5
Direct Marketing DI
06950715571583
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000001077
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Cofoe Medical Technology Co., Ltd.

See all devices from Cofoe Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Near-Patient Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED a1f098be-8e14-463c-892a-22c493ab3eed 61 fields · synced 22 Oct 2026