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blood glucose monitoring system

by Cofoe Medical Technology Co., Ltd. 10 variants

Ref KF-B12

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69507155KKIT3S7 Basic UDI-DI 06950715571804UDI-DIDate2 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  • Withdrawn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

Model / Reference
KF-B12
Primary DI / UDI-DI
06950715571804
Basic UDI-DI
69507155KKIT3S7
Direct Marketing DI
06950715571804
EMDN Code
V010402, W0101060101, W0201060102
Device Class
Class C
EU 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

  • Microbial Substances
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No