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Nox C1 Kit NOX-C1KIT1

by Nox Medical Ehf

Ref 544020Model NOX-C1KIT1

Nox C1 Kit NOX-C1KIT1 (544020) is a device classified as Class IIa in the EU and Class II in the US made by Nox Medical Ehf, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI B-15694311111146), cleared under FDA 510(k) K192469 on 13 Nov 2019 and listed in FDA GUDID since 24 Feb 2020 (UDI-DI 15694311111146), active as of 23 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192469

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-15694311111146 Basic UDI-DI 15694311111146UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15694311111146 UDI-DI Date24 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192469 Date13 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-15694311111146 registered 23 Sep 2026 Active
  • FDA 510(k) K192469 decided 13 Nov 2019 Active
  • FDA GUDID UDI-DI 15694311111146 listed 24 Feb 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192469
  2. Listed FDA GUDID 15694311111146
  3. Registered EUDAMED B-15694311111146

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Nox C1 Kit
Generic name
Polysomnograph
Model / Ref / Catalog
NOX-C1KIT1, 544020
Primary DI / UDI-DI
15694311111146
Basic UDI-DI
B-15694311111146
510(k) Number
FDA product code
OLZ, KZM
EMDN code
Z12100501 Polysomnographs
GMDN term
Polysomnograph
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1400, 890.1375
EU registration type
Legacy device (under a directive)
EU market of registration
Iceland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Polysomnograph

Cleared under the same submission (K192469)

and 8 more cleared under K192469

Similar devices in this category

Other devices filed under POLYSOMNOGRAPHS.

Other devices from Nox Medical

See all devices from Nox Medical →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)