Bernafon, Inc.

Switzerland · Bern

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, 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

16510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 16 510(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

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

19active registrations

Class 2a 19

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, 16 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: BERNAFON AG

Registration details (sample)

Market	Identifier	Name	Class / date
US	K880349	MODEL 759 CUSTOM IN-THE-EAR HEARING AID	1988-03-07
US	K874589	BERNAFON COLIBRI, C-2H HEARING AIDS	1987-12-04
US	K864823	BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1	1987-01-06
BR	10178010292	APARELHO AUDITIVO INTRA-AURICULAR MAICO/BERNAFON	Class II
BR	10178019037	APARELHO AUDITIVO RETROAURICULAR ALTENA	Class II
BR	10178010294	APARELHO AUDITIVO MINI RETROAURICULAR CAPTO	Class II
CA	102698	BERNAFON EASYCONTROL-A APP	Class II

Bernafon, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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