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VYAIRE MEDICAL FORMERLY TRADING AS CAREFUSION

USA · Yorba Linda

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, 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

11510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

64registered devices

Class I 17Class II 47

66 including historic records

SASaudi ArabiaSFDA

14registered imported devices

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

CACanadaMDALL

38active device licences

Class II 31Class III 7

102 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 2Class Im (measuring) 1

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

1registrations

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.

Australia, Hong Kong, Saudi Arabia, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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, 11 510(k), 0 PMA

Brazil64 confirmed, 0 excluded

Saudi Arabia14 confirmed, 0 excluded

Canada38 confirmed, 0 excluded

Manufacturer names merged into this page: VYAIRE MEDICAL FORMERLY TRADING AS CAREFUSION · VYAIRE MEDICAL OY · VYAIRE MEDICAL, INC. · VYAIRE MEDICAL, INC · VYAIRE MEDICAL GMBH · VYAIRE MEDICAL INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230915	AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask	2024-11-12
US	K231380	AirLife DuoTherm Humidification System	2023-08-10
US	K201082	LTV2 Series Ventilators	2021-11-10
BR	80102511704	Vital Signs® Circuito Respiratório Neonatal	Class II
BR	80102511603	Vital Signs® Circuito Respiratório para anestesia Limb-O	Class II
BR	80102511606	Vital Signs Circuito Respiratório Pediátrico com Filtro, Linha de Gás	Class II
CA	3583	PHARMASEAL SKIN SCRUB TRAY	Class III
CA	9501	TRANSPORT CIRCUIT WITH EXHALATION VALVE	Class II
CA	12802	SWIVEL-FLEX TRACH-ADAPTORS/BOWS	Class II

VYAIRE MEDICAL FORMERLY TRADING AS CAREFUSION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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