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CYFRA21-1 Assay Kit (ECLIA)

by Jiangsu Sunlant Bioengineering Co., Ltd. China EUDAMED

Ref SE-K006 EMDN W0102030111

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-SEK006DJ Basic UDI-DIDate14 Feb 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  • Withdrawn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 25 Oct 2026

Model / Reference
SE-K006
Primary DI / UDI-DI
D-SEK006DJ
Basic UDI-DI
B-SEK006DJ
EMDN Code
W0102030111 Cyfra 21-1
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025940
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Jiangsu Sunlant Bioengineering Co., Ltd.

See all devices from Jiangsu Sunlant Bioengineering Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED b03aba0f-7204-409f-a7e4-fb77c1ce0fd4 61 fields · synced 25 Oct 2026