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AnteBC

by OÜ Antegenes Estonia EUDAMED

Ref AnteBC

EMDN W02050199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04745010362019 Basic UDI-DIDate10 Apr 2023RegisteredStatusActive

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

Device Name
AnteBC, breast cancer polygenic risk score test
Model / Reference
AnteBC
Primary DI / UDI-DI
04745010362019
Basic UDI-DI
B-04745010362019
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
Device Class
Class IVD General
Market of Registration
Estonia

Manufacturer details

EUDAMED SRN
EE-MF-000028961

Other devices from OÜ Antegenes

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 782a15f3-1b42-42ce-9bb4-0846a1eaa878 61 fields · synced 22 Oct 2026