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Spectralis

by Heidelberg Engineering GmbH Germany EUDAMED

Ref 4002968Model SPECTRALIS Software V.7.4

EMDN Z12120192

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4059237-SPECTRALIS_SW-J3 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SPECTRALIS Software
Model / Reference
SPECTRALIS Software V.7.4, 4002968
Primary DI / UDI-DI
04059237000983
Basic UDI-DI
4059237-SPECTRALIS_SW-J3
Direct Marketing DI
04059237000983
EMDN Code
Z12120192 Ophtalmology assessments and diagnosis instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000008127

Other devices from Heidelberg Engineering GmbH

See all devices from Heidelberg Engineering GmbH →

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 d06a221f-f97c-452c-bb03-94924ed3ff26 61 fields · synced 24 Oct 2026