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Monaghan Medical Corporation

USA · Plattsburgh

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan — 4 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

9listed device types

Class I 4Class II 5Class III 0

plus 21 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

2valid device licences

Class II 2

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 States21 registration records, 35 510(k), 0 PMA, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MONAGHAN MEDICAL CORP. · MONAGHAN MEDICAL CORPORATION · Monaghan Medical Corporation

FDA 510(k) clearances by year

11976

51982

11983

11984

11985

11986

21987

31989

11990

41991

11993

21994

41996

11997

11999

12001

22003

12011

12013

12023

FDA listed device types

showing 8 of 9

Holding Chambers, Direct Patient Interface 1Spirometer, Therapeutic (Incentive) 1Meter, Peak Flow, Spirometry 1Nebulizer (Direct Patient Interface) 1Compressor, Air, Portable 1Mask, Oxygen, Low Concentration, Venturi 1Pump, Nebulizer, Electrically Powered 1Nebulizer, Medicinal, Non-Ventilatory (Atomizer) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220145	Monaghan medical filtered mouthpiece kit	2023-08-24
US	K123945	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17
US	K110273	AEROVENT PLUS CHC	2011-06-09
SA	ME0000018867SFDAA00001	Inhalation Chamber	—
CA	23366	AEROVENT COLLAPSIBLE HOLDING CHAMBER (CHC)	Class II

Monaghan Medical Corporation

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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