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RESMED PTY LIMITED

Australia · Bella Vista

✓ 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

18listed device types

Class I 11Class II 7Class III 0

plus 79 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class II 10

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

93active device licences

Class II 93

169 including historic records

TWTaiwanTFDA

25valid device licences

Class I 1Class II 24

SGSingaporeHSA SMDR

33device registrations

CLASS B 31CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

79active ARTG entries

Class I 57IIa 16IIb 6

HKHong KongMDACS

18valid listings

Class II 17Class III 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States79 registration records, 6 510(k), 0 PMA, 9 excluded

Brazil10 confirmed, 3 excluded

Canada93 confirmed, 4 excluded

Manufacturer names merged into this page: RESMED PTY LTD. · RESMED PTY LIMITED

Business registration

Legal name: RESMED PTY LTD
ABN: 30003765142
Registration status: Active
Legal form: Australian Private Company
Registered address: NSW, 2153

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

12020 · K203126

22023 · K230476

12024 · K234134

12025 · K242547

12026 · K251661

FDA listed device types

showing 8 of 18

Ventilator, Non-Continuous (Respirator) 1Ventilatory Effort Recorder 1Ventilator, Continuous, Non-Life-Supporting 1Sv70 Ventilator 1Continuous, Ventilator, Home Use 1Ventilator, Continuous, Facility Use 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Strap, Head, Gas Mask 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251661	Mariana Minerva; Mariana Nimbus	2026-02-23
US	K242547	AirFit F20 Mask System; AirFit F20 NM Mask System	2025-05-19
US	K234134	AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System	2024-09-24
BR	82507529004	Gerador de Fluxo para Terapia Respiratória Resmed - Série Air 11	Class II
BR	80047300686	GERADOR DE FLUXO PARA TERAPIA RESPIRATÓRIA	Class II
BR	80047300521	GERADOR DE FLUXO PARA TERAPIA RESPIRATÓRIA	Class II
CA	80	AUTOSET T NASAL CPAP SYSTEM	Class II
CA	81	SULLIVAN VPAP II	Class II
CA	82	SULLIVAN VPAP II ST	Class II