Sonova AG

Switzerland · Stafa

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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 1Class II 4Class III 0

plus 6 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 1Class II 21

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

1active device licences

Class II 1

24 including historic records

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

33device registrations

CLASS B 33

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

22active ARTG entries

Class I 6IIa 16

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 7

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, 2 510(k), 0 PMA, 5 excluded

Brazil22 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Sonova AG · SONOVA AG

FDA 510(k) clearances by year

12023 · K230538

12024 · K232999

FDA listed device types

Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Masker, Tinnitus 1Device, Assistive Listening 1Self-Fitting Air-Conduction Hearing Aid, Over The Counter 1Hearing Aid, Air-Conduction, Prescription 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232999	Lyric4 Hearing Aid	2024-04-11
US	K230538	All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid	2023-06-16
BR	81778819072	Aparelho Auditivo Retroauricular Plataforma Marvel	Class II
BR	10283319016	Aparelho auditivo Unitron Moxi B	Class II
BR	10283310179	Receptor Roger	Class II
SA	ME0000007513SFDAA00014	Naida CI Connect	—
CA	87045	FITTING SOFTWARE	Class II