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Hudson Respiratory Care, Inc.

USA · Temecula

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea — 5 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

15510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

8active device licences

Class II 8

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 5

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 States0 registration records, 15 510(k), 0 PMA, 11 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: HUDSON RESPIRATORY CARE INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K031383	MODEL 780	2003-07-07
US	K011134	OXYGEN SUPPLY TUBING, MODEL 1115	2001-06-13
US	K011125	NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI	2001-06-13
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

Hudson Respiratory Care, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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