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Hemoglobin A1C (HbA1c) Test Kit (Immunofluorescence Method)

by Wuhan Easydiagnosis Biomedicine Co., Ltd. EUDAMED

Active European Union

Ref W-IF2-HbA1c-20Model 20 tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978896415663 Basic UDI-DIDate21 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  • Withdrawn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

Device Name
Hemoglobin A1C (HbA1c) Test Kit (Immunofluorescence Method)
Model / Reference
20 tests/kit, W-IF2-HbA1c-20
Primary DI / UDI-DI
06978896415663
Basic UDI-DI
B-06978896415663
EMDN Code
W0102060109 Glycosylated/glycated haemoglobin (ic)
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.

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Properties

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