Home›Denmark›Natus Medical Denmark ApS

Natus Medical Denmark ApS

Denmark · Taastrup

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Hong Kong, Israel — 8 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

14listed device types

Class I 6Class II 7Class III 0unclassified 1

plus 24 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 2Class II 8

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

6active device licences

Class II 6

34 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

9device registrations

CLASS B 9

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

24active ARTG entries

Class I 12IIa 12

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

4registrations

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 States24 registration records, 1 510(k), 0 PMA, 8 excluded

Brazil10 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada6 confirmed, 3 excluded

Manufacturer names merged into this page: Natus Medical Denmark ApS · NATUS MEDICAL DENMARK APS

FDA 510(k) clearances by year

12025 · K242198

FDA listed device types

showing 8 of 14

Camera, Ophthalmic, Ac-Powered 1Nystagmograph 1Audiometer 1Stimulator, Auditory, Evoked Response 1Tester, Auditory Impedance 1Calibrator, Hearing Aid / Earphone And Analysis Systems 1Unit, Neonatal Phototherapy 1Stimulator, Caloric-Air 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242198	ICS Dizcovery (1091)	2025-02-14
BR	80047309223	MADSEN Zodiac	Class II
BR	80047309250	ICS® Dizcovery	Class II
BR	10293049003	AURICAL OTOCAM 300	Class I
SA	ME0000004043SFDAA00001	1093, OTOSCAN INSTRUMENT	—
SA	ME0000004043SFDAA00001	1093, OTOSCAN INSTRUMENT	—
CA	61626	CALORIC STIMULATORS	Class II
CA	61627	OAE ANALYZERS	Class II
CA	61629	REM/HIT AUDIOMETER SYSTEMS	Class II

Natus Medical Denmark ApS

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies