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Veye Lung Nodules

by Aidence B.V. Netherlands EUDAMED

Ref 3

EMDN Z11069092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberSCAR-15.2.1.1 Date26 May 2026IssuedStatusActive expires 1 Oct 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-15.2.1.1 Amended

    Quality management system EU MDR

    Notified body
    Notified body 3022
    Issued
    26 May 2026
    Expires
    1 Oct 2030
    Reason
    Other

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
3
Primary DI / UDI-DI
B865VEYELUNGNOD0310X0
Basic UDI-DI
++B865VeyeLungNodules4H
Direct Marketing DI
B865VEYELUNGNOD0310X0
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000534

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0d7372fa-04e9-43ff-8b3b-33f9177b25e3 61 fields · synced 22 Oct 2026