Skip to content

CanAg CA19-9 EIA

by Fujirebio Diagnostics AB

Ref 120-10

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-17350066140050 Basic UDI-DI 17350066140050UDI-DIDate8 Apr 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
120-10
Primary DI / UDI-DI
17350066140050
Basic UDI-DI
B-17350066140050
EMDN Code
W0102030103 Cancer antigen 19-9
Device Class
Class IVD General
EU 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

  • 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