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Nox Medical

Active in EUDAMED
Also registered as Nox Medical Ehf

Icelandfrom SRN EUDAMED FDA SRN IS-MF-000000950 FEI 3007389703

Devices
103
Registrations
EUDAMEDFDA
FDA recalls
1

What Nox Medical makes

Nox Medical manufactures respiratory monitoring devices including the Nox T3s System, Nox A1S SAS kit, T3s Recorder, and various RIP belts in different sizes, along with accessories like snap-on leads and body cables.

The company's products are classified as Class I, Class II, and Class IIa medical devices and are listed in the EU's EUDAMED and FDA's 510(k) databases. Nox Medical is based in Iceland.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue103

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Company details

EUDAMED SRN
IS-MF-000000950
SRN (system / procedure pack)
IS-PR-000054327
FDA FEI number
3007389703
EU VAT number
98087
EUDAMED status
Active
EUDAMED registered name
Nox Medical
Registered address
2, Katrinartun, 105, Reykjavik, Iceland
Phone
354 5707170
PRRC contact
Robert Magnusson(public in EUDAMED)

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Nox Medical, initiated on 2021-09-07. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2021

    • 7 Sep 2021 Z-0031-2022 Class II Terminated Error in the device firmware results in the inaccurate detection of device position. Distribution: US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD. Submission number: K082113