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Sedline 9829

by Masimo Corporation

Ref 9829Model SedLine

Sedline 9829 is a patient monitoring system module (EU MDD Class IIb; FDA Class II; FDA product code OMC, Reduced- montage standard electroencephalograph) made by Masimo Corporation, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-00843997012898) and listed in FDA GUDID since 3 Sep 2020 (UDI-DI 00843997012898), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00843997012898 Basic UDI-DI 00843997012898UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997012898 UDI-DI Date3 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00843997012898 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 00843997012898 listed 3 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00843997012898
  2. Registered EUDAMED B-00843997012898

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  • Withdrawn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
SedLine Module EUDAMED
Sedline GUDID
Generic name
Patient monitoring system module, electroencephalographic
Model / reference
9829, SedLine
Primary DI / UDI-DI
00843997012898
Basic UDI-DI
B-00843997012898
FDA product code
OMC
EMDN code
Z12100302 Electroencephalographs
GMDN term
Patient monitoring system module, electroencephalographic
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.1400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Patient monitoring system module, electroencephalographic

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

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