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INTELLIGENT HEARING SYSTEMS CORP.

USA · Miami

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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

9listed device types

Class I 0Class II 9Class III 0

plus 18 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

6 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

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 States18 registration records, 13 510(k), 0 PMA, 89 excluded

Brazil1 confirmed, 12 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada1 confirmed, 6 excluded

Manufacturer names merged into this page: INTELLIGENT HEARING SYSTEMS CORP. · INTELLIGENT SYSTEMS CO LTD · INTELLIGENT HEARING SYSTEMS

FDA 510(k) clearances by year

11991

11992

11993

11997

12003

12004

12005

22006

12007

12008

12009

12017

FDA listed device types

showing 8 of 9

Stimulator, Electrical, Evoked Response 1Cable, Electrode 1Electrode, Cutaneous 1Amplifier, Physiological Signal 1Stimulator, Photic, Evoked Response 1Audiometer 1Stimulator, Auditory, Evoked Response 1Stimulator, Nerve 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163326	SmartEP	2017-09-29
US	K090579	SMARTSCREENER-PLUS2	2009-07-07
US	K073384	SMART COUPLER, MODEL M015401	2008-02-28
BR	81771769001	EQUIPAMENTO DE POTENCIAL EVOCADO	Class II
CA	66272	SMARTUSB	Class II

INTELLIGENT HEARING SYSTEMS CORP.

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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