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Heidelberg RCM

by Gaush Neotech Ltd. China EUDAMED

Ref T3-400Model T3-600、T3-400

EMDN Z12120110

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697770338T34L Basic UDI-DIDate1 Sep 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
Corneal Confocal Microscope
Model / Reference
T3-600、T3-400, T3-400
Primary DI / UDI-DI
06977703380026
Basic UDI-DI
697770338T34L
Direct Marketing DI
06977703380026
EMDN Code
Z12120110 Corneal confocal microscopes
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000046096
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Gaush Neotech Ltd

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 3fd2c6ed-f514-4a7f-85d7-1ecdeb6ac418-1 61 fields · synced 22 Oct 2026