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TomoCaps

by Heidelberg Engineering GmbH Germany EUDAMED

Ref 18829Model TomoCap

EMDN Z12120185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0405923700001-TOMOCAP-WL Basic UDI-DIDate17 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
TomoCap
Model / Reference
TomoCap, 18829
Primary DI / UDI-DI
04059237000860
Basic UDI-DI
0405923700001-TOMOCAP-WL
Direct Marketing DI
04059237000860
EMDN Code
Z12120185 Ophtalmology assessments and diagnosis instruments - consumables
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
  • Sterile
Other properties (12)
  • 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 db65c467-2c25-4279-b3f0-fe83d50737ea 61 fields · synced 22 Oct 2026