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Be-910P

by Nihon Kohden Corp.

Ref H471

Be-910P is a device classified as Class I in the EU and Class II in the US made by Nihon Kohden Corp., registered in EUDAMED on 5 May 2026 (Basic UDI-DI 4931921MD10004BD) and listed in FDA GUDID since 29 Aug 2017 (UDI-DI 04931921863602), 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 Number4931921MD10004BD Basic UDI-DI 04931921863602UDI-DIDate5 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04931921863602 UDI-DI Date29 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4931921MD10004BD registered 5 May 2026 Active
  • FDA GUDID UDI-DI 04931921863602 listed 29 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04931921863602
  2. Registered EUDAMED 4931921MD10004BD

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  • Withdrawn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
Disk Electrode BE-910P
Generic name
Analytical scalp electrode, single-use
Device name
General-purpose multi-parameter bedside monitor
Model / Ref / Catalog
H471 EUDAMED
BE-910P GUDID
Primary DI / UDI-DI
04931921863602
Basic UDI-DI
4931921MD10004BD
FDA product code
OMA
EMDN code
Z1203020285 Multi-parameter monitors - consumables
GMDN term
Analytical scalp electrode, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
H471
GUDID
BE-910P
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Analytical scalp electrode, single-use

Other devices from Nihon Kohden Corp.

See all devices from Nihon Kohden Corp. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)