Skip to content

Electrode G (with Plastic Holder) BE-0005

by Nihon Kohden Corporation

Ref H542B

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4931921MD10014BG Basic UDI-DI 04931921891872UDI-DIDate17 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Electroencephalograph
Model / Reference
H542B
Primary DI / UDI-DI
04931921891872
Basic UDI-DI
4931921MD10014BG
EMDN Code
Z12100385 Electroencephalography instruments - consumables
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000019022
Authorised representative
NIHON KOHDEN EUROPE GmbH DE-AR-000010740

Other devices from Nihon Kohden Corporation

See all devices from Nihon Kohden Corporation →

Properties

Other properties (13)

  • 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