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blood glucose monitoring system

by Cofoe Medical Technology Co., Ltd. 10 variants

Ref GKF-B01Model KF-B12, GKF-B01, KF-B06, KF-B07, KF-B09, KF-B10

Active European Union

CE IVDR

Valid until

25 Jun 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69507155KBGMT5 Basic UDI-DI Date1 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Blood Glucose Meter
Model / Reference
KF-B12, GKF-B01, KF-B06, KF-B07, KF-B09, KF-B10
Primary DI / UDI-DI
06950715506721, 06950715506790, 06950715506738, 06950715506806
Basic UDI-DI
69507155KBGMT5
Direct Marketing DI
06950715506721
06950715506790
06950715506738
06950715506806
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class C
EU market of registration
Netherlands

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

  • 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