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NomoLine 4419

by Masimo Corporation

Ref 4419

NomoLine 4419 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 084399700000Z3T4D04V001LM) and listed in FDA GUDID since 13 Feb 2023 (UDI-DI 00843997016926), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z3T4D04V001LM Basic UDI-DI 00843997016926UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997016926 UDI-DI Date13 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z3T4D04V001LM registered 10 Aug 2026 Active
  • FDA GUDID UDI-DI 00843997016926 listed 13 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00843997016926
  2. Registered EUDAMED 084399700000Z3T4D04V001LM

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  • Withdrawn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
NomoLine ISA AX+ EUDAMED
NomoLine GUDID
Generic name
Respiration monitor
Model / Ref / Catalog
4419
Primary DI / UDI-DI
00843997016926
Basic UDI-DI
084399700000Z3T4D04V001LM
Direct marketing DI
00843997016926
FDA product code
CCK
EMDN code
Z1203020499 Gaseous exchange monitoring instruments – other
GMDN term
Respiration monitor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.1400
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 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: Respiration monitor

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

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)