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Natus Manufacturing Limited

Ireland · Gort

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, 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

27listed device types

Class I 4Class II 22Class III 0unclassified 1

plus 36 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

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

9active device licences

Class II 8Class III 1

22 including historic records

TWTaiwanTFDA

6valid device licences

Class I 1Class II 5

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Business type not stated 1Import 4

AUAustraliaTGA ARTG

10active ARTG entries

Class I 6IIa 4

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States36 registration records, 4 510(k), 0 PMA, 12 excluded

Brazil6 confirmed, 8 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada9 confirmed, 6 excluded

Manufacturer names merged into this page: Natus Manufacturing Limited · NATUS MANUFACTURING LIMITED

FDA 510(k) clearances by year

12015 · K143433

12017 · K161430

12018 · K173815

12024 · K242346

FDA listed device types

showing 8 of 27

Electrode, Needle 1Electromyograph, Diagnostic 1Device, Nerve Conduction Velocity Measurement 1Electrode, Needle, Diagnostic Electromyograph 1Stimulator, Electrical, Evoked Response 1Electrode, Cutaneous 1Nystagmograph 1Audiometer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242346	Grass® MR Conditional/CT Cup Electrodes	2024-08-29
US	K173815	Allergan Botox Needle Electrode	2018-06-29
US	K161430	Myoject Luer Lock Needle Electrode	2017-03-02
BR	80102511611	DANTEC DCN ELETRODO DE AGULHA CONCÊNTRICA DESCARTÁVEL	Class II
BR	80102511712	Teca® Eletrodos de Agulha Monopolar Descartáveis	Class II
BR	80102512707	Eletrodo Grass® Genuíno Reutilizável	Class I
CA	2286	PL-EEG SYSTEMS	Class II
CA	23261	LEADPOINT MICRO-ELECTRODE RECORDING SYSTEM	Class III
CA	60382	KEYPOINT CLINICAL SYSTEM	Class II