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Home›Norway›NORDICNEUROLAB AS

NORDICNEUROLAB AS

Norway · Bergen
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Canada, South Korea, Australia — 5 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
2listed device types
Class I 0Class II 2Class III 0
plus 6 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
Class I 8
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 States6 registration records, 13 510(k), 0 PMA
Saudi Arabia7 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: NORDICNEUROLAB AS · NordicNeuroLab AS

Company information

Country
Norway
City
Bergen

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

12007
12008
12009
12013
22014
12017
12019
12022
12023
22024
12026

FDA listed device types

System, Nuclear Magnetic Resonance Imaging 1System, Image Processing, Radiological 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251937nordicAudio (1.0)2026-03-20
USK243209nordicMEDiVA2024-10-22
USK241608nordicMEDiVA2024-06-28
SAME0000002097SFDAA00004NordicActiva—
SAME0000002097SFDAA00006ResponseGrips—
CA85749NORDICICEClass II
CA85750NORDICTUMOREXClass II

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