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Afias CA19-9

by Boditech Med Inc. EUDAMED

Active European Union

Ref SMFP-134Model AFIAS CA19-9, AFIAS Calprotectin

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number880613300639CU Basic UDI-DIDate26 Jun 2026RegisteredStatusActive
European UnionCE/IVDR Number880613300639CU Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
AFIAS Calprotectin
Model / Reference
AFIAS CA19-9, SMFP-134, AFIAS Calprotectin
Primary DI / UDI-DI
08806133043875, 08806133006399
Basic UDI-DI
880613300639CU, B-08806133006399
EMDN Code
W0102030103 Cancer antigen 19-9
Device Class
Class C
Class IVD General
Market of Registration
Romania
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000011028
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Boditech Med, Inc.

See all devices from Boditech Med, Inc. →

Properties

Show properties
  • Animal Tissues
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No