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Bis 186-0195-Sf

by Covidien LP

Ref 186-0195-SF

Bis 186-0195-Sf 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-10884521129740), cleared under FDA 510(k) K072286 on 20 Nov 2007 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 10884521129740), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K072286

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10884521129740 Basic UDI-DI 10884521129740UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521129740 UDI-DI Date13 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK072286 Date20 Nov 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10884521129740 registered 16 Oct 2026 Active
  • FDA 510(k) K072286 decided 20 Nov 2007 Active
  • FDA GUDID UDI-DI 10884521129740 listed 13 Oct 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2958-2018 FDA Class II initiated 26 Jul 2018

    Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

Timeline

4 dated events

  1. Cleared FDA 510(k) K072286
  2. Listed FDA GUDID 10884521129740
  3. Recall initiated FDA recalls Z-2958-2018
  4. Registered EUDAMED B-10884521129740

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bis
Generic name
Anaesthesia depth monitor
Device name
186-0195-Sf Generic Bis X Monitor X1
Model / reference
186-0195-SF
Primary DI / UDI-DI
10884521129740
Basic UDI-DI
B-10884521129740
510(k) Number
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

Cleared under the same submission (K072286)

and 8 more cleared under K072286

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Covidien LP

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See all devices from Covidien LP →

Properties

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