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Irma 4495

by Masimo Corporation

Ref 4495Model IRMA CO2

Irma 4495 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-07350046132306) and listed in FDA GUDID since 28 Mar 2022 (UDI-DI 07350046132306), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07350046132306 Basic UDI-DI 07350046132306UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350046132306 UDI-DI Date28 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07350046132306 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 07350046132306 listed 28 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350046132306
  2. Registered EUDAMED B-07350046132306

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  • Withdrawn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
Irmatm CO2 EUDAMED
Irma GUDID
Generic name
Respiration monitor
Model / reference
4495, IRMA CO2
Primary DI / UDI-DI
07350046132306
Basic UDI-DI
B-07350046132306
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
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: Respiration monitor

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

Other devices from Masimo Corporation

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Properties

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