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Nox Medical Ehf

Iceland · Reykjavik
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
8listed device types
Class I 1Class II 7Class III 0
plus 11 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
9 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 8 510(k), 0 PMA
Saudi Arabia0 confirmed, 1 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: NOX MEDICAL
Same-named companies — This database also contains companies with near-identical names: NOX MEDICAL. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Iceland
City
Reykjavik

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12008
12013
12015
12019
12024
22025
12026

FDA listed device types

Device, Muscle Monitoring 1Cable, Electrode 1Computerized Behavioral Therapy Device For Insomnia 1Ventilatory Effort Recorder 1Automatic Event Detection Software For Polysomnograph With Electroencephalograph 1Oximeter 1Standard Polysomnograph With Electroencephalograph 1Cannula, Nasal, Oxygen 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260585Noxturnal Web2026-03-20
USK252330DeepRESP2025-11-17
USK241960DeepRESP2025-03-14
CA95783NOX KITSClass II

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