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NEXSTIM PLC

Finland · Helsinki

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Australia — 4 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

6listed device types

Class I 0Class II 6Class III 0

plus 6 registration records and 4 510(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

0active device licences

2 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

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, 4 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: NEXSTIM PLC

FDA 510(k) clearances by year

12009 · K091457

12012 · K112881

12017 · K171902

12019 · K182700

FDA listed device types

Transcranial Magnetic Stimulator 1Stimulator, Electrical, Evoked Response 1Electromechanical Arm For A Transcranial Magnetic Stimulation System 1Electromyograph, Diagnostic 1Neurological Stereotaxic Instrument 1Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K182700	Nexstim Navigated Brain Therapy (NBT) System 2	2019-03-22
US	K171902	Nexstim Navigated Brain Therapy (NBT) System 2	2017-11-10
US	K112881	NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)	2012-05-22

NEXSTIM PLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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