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Bis 186-0212

by Covidien LP

Ref 186-0212

Bis 186-0212 is a cerebral oximeter sensor (EU MDD Class IIb; FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Covidien LP, registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI B-10884521134478) and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 10884521134478), 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-10884521134478 Basic UDI-DI 10884521134478UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521134478 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10884521134478 registered 14 Sep 2026 Active
  • FDA GUDID UDI-DI 10884521134478 listed 25 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10884521134478
  2. Registered EUDAMED B-10884521134478

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  • Withdrawn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
Cerebral oximeter sensor, single-use
Device name
186-0212 Bilateral Sensor
Model / reference
186-0212
Primary DI / UDI-DI
10884521134478
Basic UDI-DI
B-10884521134478
FDA product code
GXY
EMDN code
Z12100385 Electroencephalography instruments - consumables
GMDN term
Cerebral oximeter sensor, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.1320
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: Cerebral oximeter sensor, single-use

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHY INSTRUMENTS.

Other devices from Covidien LP

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    Class II

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)