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Cytokeratin Fragment 19（Cyfra21-1）Rapid Quantitative Test（Fluorescence Immunoassay）

by WWHS Biotech.Inc China EUDAMED

Ref CP050.B1Model 25Tests/Kit

EMDN W0102030126

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975068490596 Basic UDI-DIDate4 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
25Tests/Kit, CP050.B1
Primary DI / UDI-DI
06975068490596
Basic UDI-DI
B-06975068490596
EMDN Code
W0102030126 Cytokeratins
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000027179
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from WWHS Biotech.Inc

See all devices from WWHS Biotech.Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Companion Diagnostics
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5fa31a8e-2080-4c9b-a7bf-b0140741b2c2 61 fields · synced 22 Oct 2026