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Lumi Segment

by Augmedit B.V. EUDAMED

Active European Union

Ref 01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberSCAR-8.2.1.4 Date26 May 2026IssuedStatusActive expires 6 Oct 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-8.2.1.4 Amended

    Quality management system EU MDR

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

Specification

EUDAMED

Model / Reference
01
Primary DI / UDI-DI
08720892617613
Basic UDI-DI
87208926176LumiSegmentN7
Direct Marketing DI
08720892617613
EMDN Code
Z11069082 Various digital bioimaging management instruments - software accessories
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000045948

Other devices from Augmedit B.V.

Properties

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