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Bis 186-0224-Nk

by Covidien LP

Ref 186-0224-NK

Bis 186-0224-Nk is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-10884521533073) and listed in FDA GUDID since 17 Feb 2019 (UDI-DI 10884521533073), active as of 23 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-10884521533073 Basic UDI-DI 10884521533073UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521533073 UDI-DI Date17 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10884521533073 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 10884521533073 listed 17 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10884521533073
  2. Registered EUDAMED B-10884521533073

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Bis
Generic name
Anaesthesia depth monitor
Device name
BISX4 Nk 186-0224-Nk Nihon Kohden
Model / reference
186-0224-NK
Primary DI / UDI-DI
10884521533073
Basic UDI-DI
B-10884521533073
FDA product code
OLW
EMDN code
Z12100380 Electroencephalography instruments - hardware accessories
GMDN term
Anaesthesia depth monitor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.1400
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Anaesthesia depth monitor

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)