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Genius Cervical AI Algorithm

by Hologic United States EUDAMED

Ref SFW-04130

EMDN W02029092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54200455CYTDIGITALVM Basic UDI-DIDate3 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
SFW-04130
Primary DI / UDI-DI
15420045517363
Basic UDI-DI
54200455CYTDIGITALVM
Direct Marketing DI
15420045517363
EMDN Code
W02029092 Various hematology / histology / cytology instruments - IVD medical device software
Device Class
Class C
Special Device Type
Software
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000001677
Authorised representative
Hologic BV BE-AR-000000127

Other devices from Hologic

See all devices from Hologic →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
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
  • New Device: No

Sources (1)

  • EUDAMED 15420045517363|54200455CYTDIGITALVM 61 fields · synced 25 Oct 2026