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CoaguDx Quality Control

by Wuhan Easydiagnosis Biomedicine Co., Ltd. China EUDAMED

Ref W-CL1-QC-1Model Level 1：1 vial×1 mL Level 2：1 vial×1 mL EMDN W0103020799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978896413614 Basic UDI-DIDate27 Mar 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  • Withdrawn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

Model / Reference
Level 1：1 vial×1 mL Level 2：1 vial×1 mL, W-CL1-QC-1
Primary DI / UDI-DI
06978896413614
Basic UDI-DI
B-06978896413614
EMDN Code
W0103020799 Haemostasis controls - 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
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 561b8a21-99e4-4c51-aa6f-f90fb69efdfc 61 fields · synced 24 Oct 2026