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Cytokeratin-19-fragment Assay Kit (Chemiluminescent Immunoassay)

by Sansure Biotech Inc. United States EUDAMED

Ref S2112E-48

EMDN W0102030126

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06955792741157 Basic UDI-DIDate14 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Cytokeratin-19-fragment Assay Kit (Chemiluminescent Immunoassay)
Model / Reference
S2112E-48
Primary DI / UDI-DI
06955792741157
Basic UDI-DI
B-06955792741157
EMDN Code
W0102030126 Cytokeratins
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000011392
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sansure Biotech Inc.

See all devices from Sansure Biotech Inc. →

Properties & raw data

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

Sources (1)

  • EUDAMED 3ff6099e-4bd2-49af-8c6c-89bc4065d65e 61 fields · synced 22 Oct 2026