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Wave

by CergenX Limited Ireland EUDAMED

Ref 1.1

EMDN Z12100392

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G793WAVEKH Basic UDI-DIDate25 May 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
CergenX Wave
Model / Reference
1.1
Primary DI / UDI-DI
*+G793WAVE1D1CE0/$$7F1D1D6B1D0D3/16D20260828Y*
Basic UDI-DI
++G793WAVEKH
EMDN Code
Z12100392 Electroencephalography instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000049455

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 8b454afe-13f9-47d3-aedb-9d968121f7d4 61 fields · synced 22 Oct 2026