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ISIS Neurostimulator Komplettsystem

by inomed Medizintechnik GmbH Germany EUDAMED

Ref 504185 EMDN Z121002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42503076IGI0303A Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
504185
Primary DI / UDI-DI
04250307607457
Basic UDI-DI
42503076IGI0303A
EMDN Code
Z121002 Nervous system monitoring systems
Device Class
Class IIa
Medical Purpose
The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields: Transcranial electrical stimulation (TES) Direct cortical stimulation (DCS) Direct nerve stimulation (DNS) Transcutaneous electrical nerve stimulation (TNS) Direct muscle stimulation (DMS) Visually evoked potential (VEP) stimulation

Manufacturer details

EUDAMED SRN
DE-PR-000019534

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 04250307607457|42503076IGI0303A 61 fields · synced 25 Oct 2026