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glucose control solution

by Cofoe Medical Technology Co., Ltd. China EUDAMED

Ref level 2

EMDN W010106010801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69507155CBGCQR Basic UDI-DIDate2 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
level 2
Primary DI / UDI-DI
06950715563779
Basic UDI-DI
69507155CBGCQR
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class C
Market of Registration
Italy

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
  • Reagent
  • Self Testing
  • Near-Patient Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06950715563779|69507155CBGCQR 61 fields · synced 24 Oct 2026