Skip to content

RD Sedline 4298

by Masimo Corporation

Ref 4298

RD Sedline 4298 is a device classified as Class I in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 084399700000Z5T0B09V000LN) and listed in FDA GUDID since 13 May 2021 (UDI-DI 00843997012485), active as of 22 Oct 2026.

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

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z5T0B09V000LN Basic UDI-DI 00843997012485UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997012485 UDI-DI Date13 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z5T0B09V000LN registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00843997012485 listed 13 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00843997012485
  2. Registered EUDAMED 084399700000Z5T0B09V000LN

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
RD Sedline
Generic name
Patient monitoring system module, electroencephalographic
Device name
SedLine Patient Cables
Model / reference
4298
Primary DI / UDI-DI
00843997012485
Basic UDI-DI
084399700000Z5T0B09V000LN
Direct marketing DI
00843997012485
FDA product code
OLW
EMDN code
Z12100380 Electroencephalography instruments - hardware accessories
GMDN term
Patient monitoring system module, electroencephalographic
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)