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Home›Natus Medical Incorporated (Natus)

Natus Medical Incorporated (Natus)

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 5 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
40listed device types
Class I 9Class II 30Class III 0unclassified 1
plus 91 registration records and 36 510(k), 11 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
16registered devices
Class I 4Class II 12
18 including historic records
SASaudi ArabiaSFDA
12registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
84active device licences
Class II 72Class III 9Class IV 3
161 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 States91 registration records, 36 510(k), 11 PMA, 6 excluded
Brazil16 confirmed, 4 excluded
Saudi Arabia12 confirmed, 1 excluded
Canada84 confirmed, 3 excluded
Manufacturer names merged into this page: Natus Medical Incorporated · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) · Natus Medical Denmark ApS · NATUS MEDICAL INCORPORATED · NATUS MEDICAL INC. · NATUS MEDICAL INCORPORATED ADBA EXCEL-TECH LTD (XLTEK)
Same-named companies — This database also contains companies with near-identical names: NATUS MEDICAL INCORPORATED.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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
12025

FDA listed device types

showing 8 of 40
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 1Nystagmograph 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242198ICS Dizcovery (1091)2025-02-14
USK242930Natus BrainWatch System2024-11-19
USK233649ALGO Pro Newborn Hearing Screener (ALGO Pro)2024-03-08
BR80047309223MADSEN ZodiacClass II
BR80047309250ICS® Dizcovery™Class II
BR10293049003AURICAL OTOCAM 300Class I
SAME0000004043SFDAA000011093, OTOSCAN INSTRUMENT—
SAME0000004043SFDAA000011093, OTOSCAN INSTRUMENT—
CA5012BILI-LITE PADClass III
CA5019OLYMPIC WARM LAMPClass II
CA5076MINI BILI-LITEClass III

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