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Bis 186-0200

by Covidien LP

Ref 186-0200

Bis 186-0200 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-10884521134331), cleared under FDA 510(k) K143506 on 16 Apr 2015 (1 earlier submission) and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 10884521134331), active as of 25 Oct 2026.

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

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143506

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10884521134331 Basic UDI-DI 10884521134331UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521134331 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143506 Date16 Apr 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10884521134331 registered 16 Oct 2026 Active
  • FDA 510(k) K143506 decided 16 Apr 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521134331 listed 25 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K041670
  2. Cleared FDA 510(k) K143506
  3. Listed FDA GUDID 10884521134331
  4. Registered EUDAMED B-10884521134331

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  • Withdrawn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
Cerebral oximeter sensor, single-use
Device name
186-0200 Bis Paed Sensor
Model / reference
186-0200
Primary DI / UDI-DI
10884521134331
Basic UDI-DI
B-10884521134331
510(k) Number
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
MRI safety
MR Unsafe

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

Cleared under the same submission (K041670)

Cleared under the same submission (K143506)

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHY INSTRUMENTS.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

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