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NATUS MEDICAL INCORPORATED, DBA EXCEL-TECH LTD.

Canada

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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

27listed device types

Class I 3Class II 24Class III 0

plus 67 registration records and 35 510(k), 11 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 2Class II 4

8 including historic records

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

78active device licences

Class II 66Class III 9Class IV 3

127 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States67 registration records, 35 510(k), 11 PMA, 8 excluded

Brazil6 confirmed, 5 excluded

Saudi Arabia8 confirmed, 2 excluded

Canada78 confirmed, 4 excluded

Manufacturer names merged into this page: Natus Medical Incorporated · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) · NATUS MEDICAL INCORPORATED · NATUS MEDICAL INC. · NATUS MEDICAL INCORPORATED ADBA EXCEL-TECH LTD (XLTEK) · NATUS MEDICAL INCORPORATED.

FDA 510(k) clearances by year

21995

11998

12001

12002

12003

12005

12008

12009

42010

22011

12012

12014

12015

52016

12017

72018

12020

12021

22024

FDA listed device types

showing 8 of 27

Electrode, Cortical 1Automatic Event Detection Software For Full-Montage Electroencephalograph 1Device, Monitoring, Intracranial Pressure 1Electromyograph, Diagnostic 1Stimulator, Electrical, Evoked Response 1System, Image Processing, Radiological 1Electrode, Cutaneous 1Shunt, Central Nervous System And Components 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242930	Natus BrainWatch System	2024-11-19
US	K233649	ALGO Pro Newborn Hearing Screener (ALGO Pro)	2024-03-08
US	K203500	RetCam Envision	2021-04-13
BR	80102512057	SISTEMA AMPLIFICADOR EEG	Class II
BR	80400320005	FIXADOR DINÂMICO VAC-PAC	Class I
BR	80358749008	MINIMUFFS - PROTETOR AURICULAR PARA NEONATO	Class I
SA	ME0000000191SFDAA00001	MiniMuffs	—
SA	ME0000006691SFDAA00002	RetCam Envision Lens	—
CA	5012	BILI-LITE PAD	Class III
CA	5019	OLYMPIC WARM LAMP	Class II
CA	5076	MINI BILI-LITE	Class III

NATUS MEDICAL INCORPORATED, DBA EXCEL-TECH 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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