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RD SedlLine 4316

by Masimo Corporation

Ref 4316

RD SedlLine 4316 is a device classified as Class I in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 084399700000Z5T9B09V000RZ) and listed in FDA GUDID since 3 Jul 2020 (UDI-DI 10843997012581), active as of 7 Nov 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z5T9B09V000RZ Basic UDI-DI 10843997012581UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997012581 UDI-DI Date3 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z5T9B09V000RZ registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 10843997012581 listed 3 Jul 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 10843997012581
  2. Registered EUDAMED 084399700000Z5T9B09V000RZ

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  • Withdrawn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 Training Kit application training packet EUDAMED
RD SedlLine GUDID
Generic name
Patient monitoring system module, electroencephalographic
Device name
Sedline
Model / reference
4316
Primary DI / UDI-DI
10843997012581
Basic UDI-DI
084399700000Z5T9B09V000RZ
FDA product code
GXY
EMDN code
N01010202 EEG extracranic electrodes
GMDN term
Patient monitoring system module, electroencephalographic
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
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 EEG EXTRACRANIC ELECTRODES.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)