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Isis 504005

by inomed Medizintechnik GmbH

Ref 504005Model 504004

Isis 504005 is a device classified as Class IIa in the EU and Class II in the US made by inomed Medizintechnik GmbH, registered in EUDAMED on 12 May 2026 (Basic UDI-DI 42503076IGI01034) and listed in FDA GUDID since 16 Sep 2022 (UDI-DI 04250307607297), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503076IGI01034 Basic UDI-DI 04250307607297UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307607297 UDI-DI Date16 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503076IGI01034 registered 12 May 2026 Active
  • FDA GUDID UDI-DI 04250307607297 listed 16 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307607297
  2. Registered EUDAMED 42503076IGI01034

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ISIS Xpert System EUDAMED
Isis GUDID
Generic name
Nerve-function monitor
Device name
ISIS Xpert Plus System
Model / reference
504005, 504004
Primary DI / UDI-DI
04250307607297
Basic UDI-DI
42503076IGI01034
FDA product code
GWE, GWJ, GWF, GWQ, ETN, IKN
EMDN code
Z121002 Nervous system monitoring systems
GMDN term
Nerve-function monitor
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1890, 882.1900, 882.1870, 882.1400, 874.1820, 890.1375
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: Measurement: Auditory evoked potentials (AEP), Electroencephalography (EEG), Electrocorticography (ECoG), Electromyography (EMG), Somatosensory evoked potentials (SSEP),Motor evoked potentials (MEP), Visual evoked potentials (VEP), Microelectrode recording (MER), Bladder pressure measurement for pelvic neuromonitoring (pIONM), Train of Four (TOF) Stimulation: Transcranial electrical stimulation (TES), Direct cortical and subcortical stimulation (DCS), Direct nerve stimulation (DNS), Transcutaneous intraoperative nerve stimulation (TINS), Direct muscle stimulation (DMS), Stimulation for visual evoked potentials (VEP)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Nerve-function monitor

Similar devices

Also classified as Nerve-function monitor.

Similar devices in this category

Other devices filed under NERVOUS SYSTEM MONITORING SYSTEMS.

Other devices from inomed Medizintechnik GmbH

See all devices from inomed Medizintechnik GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)