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Natus Neurology, Incorporated

USA · Middleton

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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

32listed device types

Class I 0Class II 32Class III 0

plus 40 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 2Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

22active device licences

Class II 12Class III 8Class IV 2

45 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

6device registrations

CLASS B 3CLASS C 2CLASS D 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

8active ARTG entries

Class I 6IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 2b 1

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 States40 registration records, 5 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Saudi Arabia12 confirmed, 0 excluded

Canada22 confirmed, 0 excluded

Manufacturer names merged into this page: Natus Neurology Incorporated · NATUS NEUROLOGY INCORPORATED · Natus Neurology, Incorporated

FDA 510(k) clearances by year

12013 · K130346

12017 · K172743

12018 · K173366

12024 · K243495

12025 · K243982

FDA listed device types

showing 8 of 32

Electrode, Needle 1Electrode, Cortical 1Electromyograph, Diagnostic 1Device, Monitoring, Intracranial Pressure 1Automatic Event Detection Software For Full-Montage Electroencephalograph 1Device, Nerve Conduction Velocity Measurement 1Electrode, Needle, Diagnostic Electromyograph 1Monitor, Blood-Flow, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243982	Nicolet EDX	2025-01-22
US	K243495	Natus Ultrapro S100 (982A0594)	2024-12-12
US	K173366	NicoletOne	2018-07-20
BR	80102511778	CABO PARA AGULHA	Class I
BR	80102511540	ELETRODOS DESCARTÁVEIS	Class I
BR	80102519268	Eletromiógrafo e equipamento de resposta evocada	Class II
SA	ME0000002933SFDAA00028	Holder for Disposable Concentric Needle Electrode	—
SA	ME0000002995SFDAA00001	Disposable Ring Electrodes w/Lead	—
CA	10260	CONCENTRIC NEEDLE ELECTRODES	Class II
CA	10298	NYSTAR	Class II
CA	10314	SPIRIT	Class II

Natus Neurology, Incorporated

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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