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Respironics , Ltd.

USA · Murrysville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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

43listed device types

Class I 12Class II 31Class III 0

plus 182 registration records and 173 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

35registered devices

Class II 35

37 including historic records

SASaudi ArabiaSFDA

67registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States182 registration records, 173 510(k), 0 PMA, 15 excluded

Brazil35 confirmed, 1 excluded

Saudi Arabia67 confirmed, 6 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: RESPIRONICS INC. · Respironics, Inc. · RESPIRONICS, INC. · RESPIRONICS, INC · Respironics Inc. · Respironics, Inc

FDA 510(k) clearances by year

52003

102004

72005

62006

42007

42008

42009

62010

92011

92012

52013

22014

52015

22016

12017

52019

32020

22021

12023

12024

FDA listed device types

showing 8 of 43

Spirometer, Therapeutic (Incentive) 1Electrode, Electrocardiograph 1Nebulizer (Direct Patient Interface) 1Continuous, Ventilator, Home Use 1Ventilator, Continuous, Facility Use 1Oximeter 1Meter, Peak Flow, Spirometry 1Calculator, Pulmonary Function Data 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243394	AF531 Oro-Nasal SE Face Mask	2024-12-30
US	K231313	Therapy Mask 3100 NC/SP	2023-07-28
US	K210844	DreamWear Silicone Pillows Mask	2021-08-24
BR	10216710337	Máscara Nasal DreamWear	Class II
BR	10216710219	CONCENTRADOR DE OXIGÊNIO	Class II
BR	10216719024	Kit Dreamwisp Lab Pack	Class II
SA	ME0000008124SFDAA00001	Detachable Battery Module USA INTL	—
SA	ME0000008124SFDAA00002	Detachable Battery Pack	—

Respironics , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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