Home›USA›ETYMOTIC RESEARCH, INC.

ETYMOTIC RESEARCH, INC.

USA · Schaumberg

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

5listed device types

Class I 2Class II 3Class III 0

plus 6 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

3active device licences

Class II 3

4 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 States6 registration records, 11 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: ETYMOTIC RESEARCH, INC. · ETYMOTIC RESEARCH INC.

FDA 510(k) clearances by year

11984

11986

11987

21993

11998

22001

12007

12011

12015

FDA listed device types

Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Audiometer 1Hearing Aid, Air-Conduction, Over The Counter 1Cushion, Earphone (For Audiometric Testing) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150491	ER36 Series OAE Test System	2015-03-26
US	K112733	ER35 ERO-SCAN PRO HEARING TEST SYSTEM	2011-12-16
US	K070880	ER35 ERO-SCAN PRO HEARING TEST SYSTEM	2007-06-07
CA	105699	GOLD EARTIP ELECTRODE	Class II
CA	105747	EARTIP ELECTRODE CABLE	Class II
CA	107931	FIO	Class II

ETYMOTIC RESEARCH, INC.

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