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Carcinoembryonic Antigen (CEA) Test Kit (Immunofluorescence)

by Genrui Biotech Inc. China EUDAMED

Ref 52026123 EMDN W0102030112

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06950334813835 Basic UDI-DIDate30 May 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  • Withdrawn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
52026123
Primary DI / UDI-DI
06950334813835
Basic UDI-DI
B-06950334813835
EMDN Code
W0102030112 Carcinoembryonic antigen
Device Class
Class IVD General
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000017351
Authorised representative
Lotus NL B.V. NL-AR-000000121

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 06950334813835|B-06950334813835 61 fields · synced 25 Oct 2026