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EMG/MEP-Adapter CH.1-8 zu 504271 für farbkodiertes Zubehör

by inomed Medizintechnik GmbH

Ref 540533Model 540531

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503076IZB0408D Basic UDI-DI 04250307610631UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04250307610631 UDI-DI Date16 Sep 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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/MEP-Adapter CH.1-8 zu 504271 für farbkodiertes Zubehör EUDAMED
Isis GUDID
Generic Name
Nerve-function monitor
Device Name
EMG/MEP-Adapter Ch. 1-8 zu 504271 an ISIS Headbox 16Ch.DIF
Model / Reference
540531, 540533
Primary DI / UDI-DI
04250307610631
Basic UDI-DI
42503076IZB0408D
FDA Product Code
GWF
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
882.1870
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 I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005589

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Properties

  • Single Use
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No