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Carcinoembryonic antigen (CEA) Rapid Test

by Hangzhou Immuno Biotech Co., Ltd EUDAMED

Active European Union

Ref HCEA036Model Carcinoembryonic antigen (CEA) Rapid Test

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974238910445 Basic UDI-DIDate5 Sep 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Carcinoembryonic antigen (CEA) Rapid Test, HCEA036
Primary DI / UDI-DI
06974238910445
Basic UDI-DI
B-06974238910445
EMDN Code
W0102030112 Carcinoembryonic antigen
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001118
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

Show properties
  • 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