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Ear electrode

by TimeWaver Production GmbH Germany EUDAMED

Ref 108-4004

EMDN Z12062880

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42517842EL9J Basic UDI-DIDate5 Jun 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

Device Name
Ear Electrodes
Model / Reference
108-4004
Primary DI / UDI-DI
04251784207000
Basic UDI-DI
42517842EL9J
Direct Marketing DI
04251784207000
EMDN Code
Z12062880 Neuromuscular stimulation equipment - hardware accessories
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000010791

Other devices from Timewaver Production GmbH

  • Healy 0006

    Class II

  • Healy

    Class II

  • TimeWaver Frequency

    Class II

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 3908047e-f9c2-4f40-bb6d-e73ec76196ea 61 fields · synced 23 Oct 2026