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Neurosoft , Ltd.

Russian Federation · Ivanovo

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 8 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

16listed device types

Class I 0Class II 16Class III 0

plus 15 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class II 10

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class III 1

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

12active ARTG entries

IIa 9IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States15 registration records, 7 510(k), 0 PMA

Brazil10 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: NEUROSOFT LTD · NEUROSOFT LTD. · NEUROSOFT LLC

FDA 510(k) clearances by year

22000 · K001692

22001 · K011241

12015 · K133995

12021 · K190703

12022 · K220254

FDA listed device types

showing 8 of 16

Transcranial Magnetic Stimulator 1Stimulator, Electrical, Evoked Response 1Uroflowmeter 1Stimulator, Photic, Evoked Response 1Transmitters And Receivers, Electrocardiograph, Telephone 1Electromyograph, Diagnostic 1Audiometer 1Non-Normalizing Quantitative Electroencephalograph Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220254	Neuron-Spectrum-AM with Neuron-Spectrum.NET Software	2022-11-30
US	K190703	Neuro-IOM system with Neuro-IOM.NET software	2021-05-22
US	K133995	NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE	2015-06-19
BR	80342230001	SISTEMAS NEUROFISIOLOGICOS NEURO-MEP	Class II
BR	80342230002	SISTEMAS NEUROFISIOLOGICOS NEURON-SPECTRUM	Class II
BR	80969860039	Eletrodo Vagus C3P2	Class II
CA	95202	FOCUS EMG DEVICE	Class III

Neurosoft , Ltd.

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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