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Advanced Bionics Corp.

USA · Valencia

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

1listed device types

Class I 0Class II 0Class III 1

plus 2 registration records and 0 510(k), 172 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

15active device licences

Class II 11Class III 4

56 including historic records

TWTaiwanTFDA

16valid device licences

Class I 1Class III 15

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

47active ARTG entries

Class I 19Class III 21IIa 7

HKHong KongMDACS

2valid listings

Class III 1Class IV 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

5active registrations

Class 2b 4Class 3 1

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 States2 registration records, 0 510(k), 172 PMA, 16 excluded

Brazil1 confirmed, 1 excluded

Canada15 confirmed, 0 excluded

Manufacturer names merged into this page: Advanced Bionics North American Operations Center S.A. de C.V. · Advanced Bionics LLC · ADVANCED BIONICS, LLC · Advanced Bionics Instrumentos Auditivos do Brasil Ltda.

Market	Identifier	Name	Class / date
BR	80824109002	Sistema AIM	Class II
CA	62702	HIRESOLUTION AURIA	Class III
CA	70578	AURIA HARMONY	Class III
CA	376	CLARION MULTI-STRATEGY COCHLEAR IMPLANT SYSTEM	Class III

Advanced Bionics Corp.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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