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COCHLEAR LIMITED

Australia · Macquarie Park

✓ 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

8listed device types

Class I 2Class II 3Class III 3

plus 23 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

17 including historic records

SASaudi ArabiaSFDA

31registered imported devices

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

CACanadaMDALL

10active device licences

Class II 3Class III 7

38 including historic records

TWTaiwanTFDA

17valid device licences

Class I 3Class II 1Class III 13

SGSingaporeHSA SMDR

22device registrations

CLASS C 12CLASS D 10

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

277active ARTG entries

Class I 200Class III 69IIa 7IIb 1

HKHong KongMDACS

14valid listings

Class II 1Class III 5Class IV 8

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

8active registrations

Class 2a 1Class 2b 3Class 3 4

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 States23 registration records, 3 510(k), 0 PMA, 8 excluded

Brazil3 confirmed, 3 excluded

Saudi Arabia31 confirmed, 1 excluded

Canada10 confirmed, 3 excluded

Manufacturer names merged into this page: COCHLEAR LTD. · Cochlear Ltd · COCHLEAR LIMITED · COCHLEAR LTD · Cochlear Limited

Business registration

ABN: 96002618073
Registration status: Active
Legal form: Australian Public Company
Registered address: NSW, 2109

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22023 · K231204

12025 · K250215

FDA listed device types

Implant, Cochlear 1Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification 1Implant, Auditory Brainstem 1Medical Device Data System 1Instrument, Ent Manual Surgical 1Hearing Aid, Bone Conduction 1Active Implantable Bone Conduction Hearing System 1Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250215	Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand	2025-05-29
US	K231204	Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App	2023-08-18
US	K223672	Instrument Case P1340904	2023-03-21
BR	10178010310	Instrumentais cirúrgicos auxiliares de implantes de condução óssea	Class I
BR	10178010312	Instrumentais cirúrgicos auxiliares de implantes cocleares	Class I
BR	10178019047	Instrumentais de uso único para cirurgias de implantes cocleares	Class II
SA	ME0000001632SFDAA00043	Nucleus® 7 Aqua+	—
SA	ME0000001632SFDAA00051	Cochlear™ Coil Spacer	—
CA	64552	NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM	Class III
CA	64553	NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS	Class III
CA	64555	NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN	Class III