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Vyaire Medical, Inc.

USA · Helsinki

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

9valid device licences

Class I 2Class II 7

SGSingaporeHSA SMDR

5device registrations

CLASS B 3CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

39active ARTG entries

Class I 16IIa 19IIb 3Class Is (sterile) 1

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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, 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
SA	ME0000002200SFDAA00001	Pressure Infusor	—
SA	ME0000000650SFDAA00034	Vital Signs Cardiac Output	—
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, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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