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Respiratory Care, Inc.

USA · Mchenry

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

8listed device types

Class I 0Class II 8Class III 0

plus 2 registration records and 44 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 1Class II 6

12 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

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 States2 registration records, 44 510(k), 0 PMA, 28 excluded

Brazil7 confirmed, 2 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada8 confirmed, 9 excluded

Manufacturer names merged into this page: Philips India Limited - Sleep & Respiratory Care Business Unit · HUDSON RESPIRATORY CARE INC. · RESPIRATORY CARE HOSPITALAR LTDA

FDA 510(k) clearances by year

61978

11979

11980

21981

21983

11984

31986

21988

11989

11990

11993

21994

31996

11997

32000

32001

12003

12006

12008

12011

FDA listed device types

Ventilator, Non-Continuous (Respirator) 1Ventilatory Effort Recorder 1Automatic Event Detection Software For Polysomnograph With Electroencephalograph 1Generator, Oxygen, Portable 1Sv70 Ventilator 1Continuous, Ventilator, Home Use 1Ventilator, Continuous, Non-Life-Supporting 1Ventilator, Continuous, Facility Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K100928	MICRO DIARY SPIROMETER	2011-03-07
US	K073069	MODIFICATION TO AVEA VENTILATOR	2008-01-25
US	K062093	AVEA VENTILATOR	2006-09-20
BR	80113019023	Sensores de SpO2 RTC	Class II
BR	80113010008	Reservatório para Umidificação	Class II
BR	80113010027	CABO PARA ECG RTC	Class II
CA	4897	KENDALL SHERIDAN LASER-TRACHEAL TUBE	Class II
CA	5003	KENDALL SHERIDAN CO2 MONITORING TRACTICAL TUBE	Class II
CA	5119	KENDALL SHERIDAN TEMPERATURE SENSOR	Class II

Respiratory Care, Inc.

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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