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Trudell Medical

Canada · London

✓ 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

7listed device types

Class I 2Class II 5Class III 0

plus 20 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

11active device licences

Class II 11

30 including historic records

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 States20 registration records, 27 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada11 confirmed, 1 excluded

Manufacturer names merged into this page: TRUDELL MEDICAL INTERNATIONAL · TRUDELL MEDICAL INTERNATIONAL INC. ADBA TRUDELL MEDICAL INTERNATIONAL

Same-named companies — This database also contains companies with near-identical names: TRUDELL MEDICAL INTERNATIONAL, TRUDELL MEDICAL INTERNATIONAL INC. ADBA TRUDELL MEDICAL INTERNATIONAL. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11998

21999

12000

12002

12004

12005

12006

12007

12008

12009

12011

12012

32013

12014

12015

32018

22019

12020

12021

12025

FDA listed device types

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242667	AeroChamber2go Anti-Static Valved Holding Chamber	2025-01-15
US	K203400	Corrugated tube with mouthpiece accessory	2021-06-14
US	K200063	AeroEclipse* ONE BAN	2020-07-17
BR	81504790311	Aerobika	Class I
CA	14140	AERO ECLIPSE NEBULIZER	Class II
CA	36613	AEROPEP PLUS VALVED HOLDING CHAMBER	Class II
CA	63100	AEROCHAMBER MAX VALVED HOLDING CHAMBER (VHC)	Class II

Trudell Medical

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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