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Isis 504285

by inomed Medizintechnik GmbH

Ref 504285

Isis 504285 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 31 Aug 2026 (Basic UDI-DI B-04250307607563) and listed in FDA GUDID since 5 Sep 2022 (UDI-DI 04250307607563), active as of 23 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-04250307607563 Basic UDI-DI 04250307607563UDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307607563 UDI-DI Date5 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250307607563 registered 31 Aug 2026 Active
  • FDA GUDID UDI-DI 04250307607563 listed 5 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307607563
  2. Registered EUDAMED B-04250307607563

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ISIS Headbox 8Ch. DIF - 8Ch. REF - AEP EUDAMED
Isis GUDID
Generic name
Nerve-function monitor
Model / reference
504285
Primary DI / UDI-DI
04250307607563
Basic UDI-DI
B-04250307607563
FDA product code
GWF, GWE, GWJ, 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
882.1870, 882.1890, 882.1900, 882.1400, 874.1820, 890.1375
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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 (20, all answered No)