HomeUSARESMED LIMITED

RESMED LIMITED

USA · San Diego
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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
20listed device types
Class I 11Class II 9Class III 0
plus 100 registration records and 122 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 4
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
2valid device licences
Class II 2
SGSingaporeHSA SMDR
25device registrations
CLASS B 23CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 1IIa 2IIb 1
HKHong KongMDACS
6valid listings
Class II 6
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
pendingnot queried
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 States100 registration records, 122 510(k), 0 PMA, 7 excluded
Brazil4 confirmed, 2 excluded
Canada1 confirmed, 4 excluded
Manufacturer names merged into this page: RESMED CORP · ResMed Corp · RESMED CORP. · RESMED LIMITED

Company information

Country
USA
City
San Diego

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
RESMED INC
CIK
0000943819
Registration status
Active
Listing status
Listed (RMD)

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

FDA 510(k) clearances by year

102004
52005
42006
62007
62008
102009
52010
82011
82012
72013
72014
32015
82016
22017
32018
12019
12021
22024
22025
32026

FDA listed device types

showing 8 of 20
Sleeve, Limb, Compressible 1Ventilator, Non-Continuous (Respirator) 1Ventilatory Effort Recorder 1Continuous, Ventilator, Home Use 1Sv70 Ventilator 1Ventilator, Continuous, Non-Life-Supporting 1Ventilator, Continuous, Facility Use 1Generator, Oxygen, Portable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253553Orion2026-06-04
USK254104ResScan Essentials2026-05-27
USK251889myAir2026-04-08
BR82507520003myAirClass II
BR82507520001AirViewClass II
BR82507529002ResMed Masks IXClass II
CA74870SULLIVAN PASSOVER HUMIDIFIERClass II

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