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Neurowave Systems, Inc.

USA · Beachwood

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 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

5listed device types

Class I 0Class II 5Class III 0

plus 1 registration records and 3 510(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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States1 registration records, 3 510(k), 0 PMA

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: NEUROWAVE SYSTEMS INC.

FDA 510(k) clearances by year

12010 · K092477

12015 · K142834

12021 · K202621

FDA listed device types

Burst Suppression Detection Software For Electroencephalograph 1Index-Generating Electroencephalograph Software 1Electrode, Cutaneous 1Non-Normalizing Quantitative Electroencephalograph Software 1Reduced- Montage Standard Electroencephalograph 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202621	NeuroSENSE Monitoring System, Model NS-901	2021-08-05
US	K142834	DiscoverEEG System, Model DE-401	2015-06-23
US	K092477	NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701	2010-10-29

Neurowave Systems, Inc.

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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