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Optomed Lumo Camera

by Optomed Oyj Finland EUDAMED

Ref 41002003

EMDN Z12120199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI24/00000061 Date17 Jun 2025IssuedStatusActive expires 16 Jun 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI24/00000061 Reissued

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    17 Jun 2025
    Expires
    16 Jun 2030

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Optomed Lumo
Model / Reference
41002003
Primary DI / UDI-DI
06430046260962
Basic UDI-DI
643004626camera208G
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class IIa
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000009407

Other devices from Optomed Oyj

See all devices from Optomed Oyj →

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 f06bf49d-2e53-4487-bc57-08588420d8f0 61 fields · synced 22 Oct 2026