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Nomoline 4412

by Masimo Corporation

Ref 4412

Nomoline 4412 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 084399700000Z3T4D01V000KJ), cleared under FDA 510(k) K171121 on 17 Nov 2017 and listed in FDA GUDID since 3 Jul 2020 (UDI-DI 00843997014762), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171121

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z3T4D01V000KJ Basic UDI-DI 00843997014762UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997014762 UDI-DI Date3 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171121 Date17 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z3T4D01V000KJ registered 30 Sep 2026 Active
  • FDA 510(k) K171121 decided 17 Nov 2017 Active
  • FDA GUDID UDI-DI 00843997014762 listed 3 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171121
  2. Listed FDA GUDID 00843997014762
  3. Registered EUDAMED 084399700000Z3T4D01V000KJ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
NomoLine ISA CO2 EUDAMED
Nomoline GUDID
Generic name
Respiration monitor
Device name
Isa
Model / reference
4412
Primary DI / UDI-DI
00843997014762
Basic UDI-DI
084399700000Z3T4D01V000KJ
Direct marketing DI
00843997014762
510(k) Number
FDA product code
MWI
EMDN code
R020108 Respiratory gas monitoring and sampling circuits and kits
GMDN term
Respiration monitor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2300
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

Cleared under the same submission (K171121)

and 8 more cleared under K171121

Similar devices in this category

Other devices filed under RESPIRATORY GAS MONITORING AND SAMPLING CIRCUITS AND KITS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Measuring function
  • Prescription use
  • Manufacturing date
Other properties (22, all answered No)