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Hemoglobin A1C (HbA1c) Test Kit (Immunofluorescence Method)

by Wuhan Easydiagnosis Biomedicine Co., Ltd. China EUDAMED

Ref W-IF-HbA1c-20Model 20 tests/kit EMDN W0102060199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973720135700 Basic UDI-DIDate14 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Hemoglobin A1C (HbA1c) Test Kit (Immunofluorescence Method)
Model / Reference
20 tests/kit, W-IF-HbA1c-20
Primary DI / UDI-DI
06973720135700
Basic UDI-DI
B-06973720135700
EMDN Code
W0102060199 Diabetes assays - other
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000019908
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Wuhan Easydiagnosis Biomedicine Co., Ltd.

See all devices from Wuhan Easydiagnosis Biomedicine Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 6445039b-cb44-4c36-8a83-cda93d8e784c 61 fields · synced 24 Oct 2026