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Spectralis

by Heidelberg Engineering GmbH Germany EUDAMED

Ref 600300Model SPECTRALIS SP 1.19

EMDN Z12120121

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0405923700001-SP-ZH Basic UDI-DIDate14 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SPECTRALIS SP 1.19, 600300
Primary DI / UDI-DI
04059237000808
Basic UDI-DI
0405923700001-SP-ZH
Direct Marketing DI
04059237000808
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 04059237000808|0405923700001-SP-ZH 61 fields · synced 24 Oct 2026