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Cytokeratin-19-fragment (CYFRA21-1) Detection Kit（Magnetic Solid Phase Chemiluminescent）

by Biobase Diagnostic Technology (Shandong) Co., Ltd. China EUDAMED

Ref 100 Tests/kit（DR1096-2）Model 100 Tests/kit

EMDN W0102030111

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974969981936 Basic UDI-DIDate11 May 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
100 Tests/kit, 100 Tests/kit（DR1096-2）
Primary DI / UDI-DI
06974969981936
Basic UDI-DI
B-06974969981936
EMDN Code
W0102030111 Cyfra 21-1
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025964
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Biobase Diagnostic Technology (Shandong) Co., Ltd.

See all devices from Biobase Diagnostic Technology (Shandong) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b79eb2c4-9552-4d76-a659-b6bb143361e4 61 fields · synced 22 Oct 2026