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Je-226AK

by Nihon Kohden Corporation

Part of a family of 62 devices: see the family page

Ref JE-226AK

Je-226AK is a device classified as Class I in the EU and Class II in the US made by Nihon Kohden Corporation, registered in EUDAMED on 17 May 2026 (Basic UDI-DI 4931921MD10014BG) and listed in FDA GUDID since 5 Sep 2016 (UDI-DI 04931921108826), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4931921MD10014BG Basic UDI-DI 04931921108826UDI-DIDate17 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04931921108826 UDI-DI Date5 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4931921MD10014BG registered 17 May 2026 Active
  • FDA GUDID UDI-DI 04931921108826 listed 5 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04931921108826
  2. Registered EUDAMED 4931921MD10014BG

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  • Withdrawn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
Mini Flat Junction Box JE-226AK
Generic name
Electroencephalograph
Device name
Electroencephalograph
Model / Ref / Catalog
JE-226AK
Primary DI / UDI-DI
04931921108826
Basic UDI-DI
4931921MD10014BG
FDA product code
GWQ, GYC, OLT
EMDN code
Z12100380 Electroencephalography instruments - hardware accessories
GMDN term
Electroencephalograph
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1400, 882.1310
EU registration type
Standard device
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

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: Electroencephalograph

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Nihon Kohden Corporation

See all devices from Nihon Kohden Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)