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APTT CoaguDx Test Strip

by Wuhan Easydiagnosis Biomedicine Co., Ltd. EUDAMED

Active European Union

Ref W-CL1-APTT-SC-48Model 48 Strips / Kit (Note: One-step method)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978896413720 Basic UDI-DIDate2 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  • Withdrawn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

Model / Reference
48 Strips / Kit (Note: One-step method), W-CL1-APTT-SC-48
Primary DI / UDI-DI
06978896413720
Basic UDI-DI
B-06978896413720
EMDN Code
W0103020102 Activated partial thromboplastin time
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

  • 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