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Aiforia® Clinical AI Model for Breast Cancer; ER

by Aiforia Technologies Plc

Ref Aiforia® Clinical AI Model for Breast Cancer; ER

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-06429810612038 Basic UDI-DI 06429810612038UDI-DIDate30 Sep 2025RegisteredStatusActive

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  • Withdrawn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
Aiforia® Clinical AI Model for Breast Cancer, ER
Primary DI / UDI-DI
06429810612038
Basic UDI-DI
B-06429810612038
EMDN Code
W0202050392 Laboratory instruments for microscopic investigations - IVD medical device software
Models / Variants
Device Class
Class IVD General
Special Device Type
-1202
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000008986

Other devices from Aiforia Technologies Plc

See all devices from Aiforia Technologies Plc →

Properties

  • 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