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SPECTRALIS Platform

by Heidelberg Engineering GmbH Germany EUDAMED

Ref 88033Model SPECTRALIS Platform DMR024

EMDN Z12120121

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4059237-SPECTRALIS_HW-GC 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 23 Oct 2026

Model / Reference
SPECTRALIS Platform DMR024, 88033
Primary DI / UDI-DI
04059237001010
Basic UDI-DI
4059237-SPECTRALIS_HW-GC
Direct Marketing DI
04059237001010
EMDN Code
Z12120121 Optical consistency tomographs
Device Class
Class IIa
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 cd0f04ca-d2c9-4164-b07f-cbdf74eff553 61 fields · synced 23 Oct 2026