Phonak, Inc.

Switzerland · Naperville

✓ Record-verifiedregistrations found in 6 markets

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

39510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 39 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

15active registrations

Class 2a 15

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 States0 registration records, 39 510(k), 0 PMA

Brazil3 confirmed, 1 excluded

Manufacturer names merged into this page: PHONAK AG. · PHONAK AG

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130790	LYRIC2	2013-06-27
US	K123450	PHONAK TINNITUS BALANCE	2013-02-11
US	K972106	PHONAK NOVO FORTE E3	1997-08-15
BR	10356330021	ITE APARELHO AUDITIVO UNITRON INTRAURICULAR DIGITAL	Class II
BR	10356330022	BTE APARELHO AUDITIVO UNITRON RETROAURICULAR DIGITAL	Class II
BR	10283310137	Receptor Roger	Class II

Phonak, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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