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INTERACOUSTICS A/S

Denmark · Middelfart

✓ Record-verifiedregistrations found in 10 markets

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

16listed device types

Class I 6Class II 9Class III 0unclassified 1

plus 46 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

21registered devices

Class I 1Class II 20

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

11active device licences

Class II 11

42 including historic records

TWTaiwanTFDA

13valid device licences

Class I 4Class II 9

SGSingaporeHSA SMDR

19device registrations

CLASS B 19

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 2IIa 5

HKHong KongMDACS

9valid listings

Class II 9

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

11active registrations

Class 2a 11

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 States46 registration records, 17 510(k), 0 PMA, 2 excluded

Brazil21 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: INTERACOUSTICS A/S · Interacoustics A/S

FDA 510(k) clearances by year

12006

12007

12008

12010

12011

12012

22013

22015

22017

12018

12019

32020

FDA listed device types

showing 8 of 16

Rhinoanemometer (Measurement Of Nasal Decongestion) 1Cable, Electrode 1Electrode, Cutaneous 1Nystagmograph 1Audiometer 1Tester, Auditory Impedance, Exempt 1Stimulator, Auditory, Evoked Response 1Tester, Auditory Impedance 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200534	VisualEyes	2020-08-12
US	K200529	Orion	2020-08-12
US	K192652	TRV	2020-05-27
BR	10356020048	AUDIOMETRO DE RESPOSTAS EVOCADAS DO TRONCO CEREBRAL	Class II
BR	10356029048	Audiômetro Equinox Evo	Class II
BR	10372700036	AUDIOMETRO DE IMPEDANCIA INTERACOUSTICS	Class II
SA	ME0000000219SFDAA00013	TRV Chair	—
CA	2539	STARKEY ACOUSTIC ANALYZER AA30	Class II
CA	65682	HEARING AID ANALYZERS	Class II
CA	66911	RHINOMETRICS UNITS	Class II

INTERACOUSTICS A/S

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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