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Devilbiss Health Care, Inc.

USA · Somerset

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, 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 14 registration records and 36 510(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

44active device licences

Class II 44

55 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 States14 registration records, 36 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada44 confirmed, 1 excluded

Manufacturer names merged into this page: DeVilbiss Healthcare LLC. · DEVILBISS HEALTHCARE LLC · DeVilbiss Healthcare LLC

FDA 510(k) clearances by year

71989

21990

41991

21992

31993

11994

41995

41996

21997

12011

12014

12015

12016

12018

12025

12026

FDA listed device types

Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Nebulizer (Direct Patient Interface) 1Bottle, Collection, Vacuum 1Generator, Oxygen, Portable 1Compressor, Air, Portable 1Adaptor, Recreational 1Nebulizer, Medicinal, Non-Ventilatory (Atomizer) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253549	DeVilbiss 5 Liter Oxygen Concentrator (555)	2026-03-26
US	K250805	DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)	2025-12-09
US	K172648	Drive DeVilbiss iGo 2 Portable Oxygen Concentrator	2018-03-23
SA	ME0000002775SFDAA00001	Aluminum wheelchair	—
CA	6418	DEVILBISS HEAVY DUTY AEREOSOL COMPRESSOR	Class II
CA	16184	DEVILBISS SERENITY MASK	Class II
CA	18167	DEVILBISS REUSABLE NEBULIZER	Class II

Devilbiss Health Care, Inc.

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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