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540425

by inomed Medizintechnik GmbH

Ref 540425Model 540434

540425 is a device classified as Class I in the EU and Class II in the US made by inomed Medizintechnik GmbH, registered in EUDAMED on 24 Oct 2025 (Basic UDI-DI 42503076IZC0128F) and listed in FDA GUDID since 16 Dec 2022 (UDI-DI 04250307604586), 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 Number42503076IZC0128F Basic UDI-DI 04250307604586UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307604586 UDI-DI Date16 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503076IZC0128F registered 24 Oct 2025 Active
  • FDA GUDID UDI-DI 04250307604586 listed 16 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250307604586
  2. Registered EUDAMED 42503076IZC0128F

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  • Withdrawn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
EMG-Elektroden-Minibox 4-Kanal mit Ground
Generic name
Nerve-function monitor
Device name
SEP Box 2K für C2 Xplore
Model / reference
540425, 540434
Primary DI / UDI-DI
04250307604586
Basic UDI-DI
42503076IZC0128F
FDA product code
IKD
EMDN code
Z12109080 Various neurology and neurosurgery instruments - hardware accessories
GMDN term
Nerve-function monitor
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.1175
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from inomed Medizintechnik GmbH

See all devices from inomed Medizintechnik GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)