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D-Dimer Detection Kit (Nephelometry)

by Genrui Biotech Inc. China EUDAMED

Ref 32027164

EMDN W0103020503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06950334819714 Basic UDI-DIDate27 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

TürkiyeTürkiyeTürkiyeTürkiyeTürkiyeTürkiye
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

EU market availability

Available in 1 country, as listed in EUDAMED:

  • Türkiye

Last checked 25 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
32027164
Primary DI / UDI-DI
06950334819714
Basic UDI-DI
B-06950334819714
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000017351
Authorised representative
Medunion S.L. ES-AR-000019366

From the manufacturer

Manufacturer's product page: LungeKlar® Seven Lung Cancer-associated Autoantibodies Detection Kit (CLIA)

Other devices from Genrui Biotech Inc.

See all devices from Genrui Biotech Inc. →

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 06950334819714|B-06950334819714 61 fields · synced 25 Oct 2026