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Starkey Laboratories, Inc.

USA · Eden Prairie

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 7 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

3listed device types

Class I 1Class II 2Class III 0

plus 4 registration records and 61 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class II 19

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

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

51device registrations

CLASS B 51

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

Class I 7IIa 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

12active registrations

Class 2a 12

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 States4 registration records, 61 510(k), 0 PMA, 4 excluded

Brazil19 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Starkey Laboratories, Inc. · STARKEY LABORATORIES, INC.

FDA 510(k) clearances by year

21977

21978

91979

11980

11982

11984

51988

41990

11991

21992

81993

121994

71996

31997

12003

12012

12020

FDA listed device types

Hearing Aid, Air-Conduction, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Masker, Tinnitus 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201370	Multiflex Tinnitus Technology	2020-06-19
US	K122876	MULTIFLEX TINNITUS TECHNOLOGY	2012-10-31
US	K030180	CRESCENT TINNITUS RETAINING SOUND GENERATOR	2003-09-17
BR	80179159001	Aparelho Digital para Surdez Intra Auricular (ITE) e Intra Canal (ITC)	Class II
BR	80179159015	Aparelho Auditivo Receptor no Canal	Class II
BR	80179159016	Aparelho Auditivo	Class II

Starkey Laboratories, Inc.

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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