Skip to content

CanAg CA15-3 EIA

by Fujirebio Diagnostics AB United States EUDAMED

Ref 200-10

EMDN W0102030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-17350066140081 Basic UDI-DIDate8 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
200-10
Primary DI / UDI-DI
17350066140081
Basic UDI-DI
B-17350066140081
EMDN Code
W0102030102 Cancer antigen 15-3
Device Class
Class IVD General
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000007811

Other devices from Fujirebio Diagnostics AB

See all devices from Fujirebio Diagnostics AB →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED ae293f6b-905b-45af-8854-81452e842344 61 fields · synced 22 Oct 2026