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Lesion Ranking Software

by Neko Health AB Sweden EUDAMED

Ref Lesion Ranking Software

EMDN Z12040192

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735017092_LSR_JL Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-28.2.1.0 Issued

    Quality management system EU MDR

    Notified body
    Notified body 3022
    Issued
    20 Oct 2026
    Expires
    19 Oct 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Lesion Ranking Software
Model / Reference
Lesion Ranking Software
Primary DI / UDI-DI
07350170921005
Basic UDI-DI
735017092_LSR_JL
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIa
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000045605

Other devices from Neko Health AB

See all devices from Neko Health AB →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 07350170921005|735017092_LSR_JL 61 fields · synced 24 Oct 2026