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NomoLine ISA™ AX+ 9923

by Masimo Corporation

Ref 9923

NomoLine ISA™ AX+ 9923 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 11 Aug 2016 (UDI-DI 00843997016964), 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 00843997016964UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997016964 UDI-DI Date11 Aug 2016ListedStatusListed 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 00843997016964 listed 11 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00843997016964
  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  • Withdrawn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 ISA™ AX+ GUDID
Generic name
Patient monitoring system module, multiple-gas
Model / Ref / Catalog
9923
Primary DI / UDI-DI
00843997016964 EUDAMED
07350046131859 GUDID
Basic UDI-DI
084399700000Z3T4D04V001LM
Direct marketing DI
00843997016964
FDA product code
NHQ, NHP, NHO, CBS, CBR, CBQ, CCK
EMDN code
Z1203020499 Gaseous exchange monitoring instruments – other
GMDN term
Patient monitoring system module, multiple-gas
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.1500, 868.1620, 868.1700, 868.1400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00843997016964
GUDID
07350046131859
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00843997016964; FDA GUDID lists 07350046131859), so their flags are not compared. 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, multiple-gas

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
Other properties (22, all answered No)