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Aiforia® Breast Cancer Grading

by Aiforia Technologies Plc

Ref Aiforia® Breast Cancer Grading

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDR Number06429810612BR005KG Basic UDI-DI 06429810612113UDI-DIDate5 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
Aiforia® Breast Cancer Grading
Primary DI / UDI-DI
06429810612113
Basic UDI-DI
06429810612BR005KG
Direct Marketing DI
06429810612113
EMDN Code
W0202050392 Laboratory instruments for microscopic investigations - IVD medical device software
Device Class
Class C
Special Device Type
Software
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
  • New Device

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