Skip to content

Automatic Glycohemoglobin Analyzer

by Guangzhou Wondfo Biotech Co., Ltd. China EUDAMED

Ref WK02Model P10, P60

EMDN W0201050201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69332898CE5100F8 Basic UDI-DIDate6 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
P10, P60, WK02
Primary DI / UDI-DI
06933289831673
Basic UDI-DI
69332898CE5100F8
EMDN Code
W0201050201 High performance liquid chromatography systems
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000000689
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Guangzhou Wondfo Biotech Co., Ltd.

See all devices from Guangzhou Wondfo Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 06933289831673|69332898CE5100F8 61 fields · synced 25 Oct 2026