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Natus Medical Incorporated, DBA Excel - Tech Ltd. (XLTEK)

Canada · Oakville Ontario

✓ 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

20listed device types

Class I 1Class II 19Class III 0

plus 34 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

42active device licences

Class II 40Class III 1Class IV 1

77 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 States34 registration records, 19 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada42 confirmed, 0 excluded

Manufacturer names merged into this page: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) · NATUS MEDICAL INCORPORATED ADBA EXCEL-TECH LTD (XLTEK) · NATUS MEDICAL INCORPORATED DBA XLTEK · Natus Medical Incorporated, DBA Excel - Tech Ltd. (XLTEK) · natus medical incorporated DBA Excel Tech Ltd XLTEK

Same-named companies — This database also contains companies with near-identical names: Excel Tech. , Ltd., Excel-Tech Ltd. (Xltek), NATUS MEDICAL INCORPORATED ADBA EXCEL-TECH LTD (XLTEK), NATUS MEDICAL INCORPORATED DBA XLTEK. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12008

12010

12011

12012

12013

12014

32016

12017

52018

12020

12021

22024

FDA listed device types

showing 8 of 20

Electrode, Cortical 1Automatic Event Detection Software For Full-Montage Electroencephalograph 1Electromyograph, Diagnostic 1Stimulator, Electrical, Evoked Response 1System, Image Processing, Radiological 1Electrode, Cutaneous 1Non-Normalizing Quantitative Electroencephalograph Software 1Stimulator, Auditory, Evoked Response 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	80380269008	Sistema de Captura de imagem RETCAM ENVISION	Class II
SA	ME0000006691SFDAA00002	RetCam Envision Lens	—
SA	ME0000006691SFDAA00001	RetCam Envision System	—
CA	500	CEREBRAL FUNCTION MONITOR CFM 6000	Class III
CA	2069	ISOTRON 220 ISOTRON AND 1000 PLUS POWERED MUSCLE STIMULATOR	Class II
CA	2070	ISOTRON II, ISOTRON III, ISOTRON IV 2 CHANNEL ELECTRO MUSCLE STIMULATOR	Class II

Natus Medical Incorporated, DBA Excel - Tech Ltd. (XLTEK)

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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