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Drive DeVilbiss Healthcare

USA · Dayton

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel — 7 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

27listed device types

Class I 21Class II 6Class III 0

plus 105 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 4Class II 1

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

49active device licences

Class II 49

74 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

Class I 13

HKHong KongMDACS

pendingnot queried

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, Saudi Arabia, Singapore, 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 States105 registration records, 7 510(k), 0 PMA, 2 excluded

Brazil5 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada49 confirmed, 0 excluded

Manufacturer names merged into this page: Drive DeVilbiss Healthcare · DeVilbiss Healthcare LLC. · DEVILBISS HEALTHCARE LLC · DRIVE MEDICAL, DBA DRIVE DEVILBISS HEALTHCARE · MEDICAL DEPOT, INC. DBA DRIVE DEVILBISS HEALTHCARE · DRIVE DEVILBISS SIDHIL LTD.

Same-named companies — This database also contains companies with near-identical names: DeVilbiss Healthcare LLC., Drive DeVilbiss Healthcare France, DRIVE MEDICAL, DBA DRIVE DEVILBISS HEALTHCARE, MEDICAL DEPOT, INC. DBA DRIVE DEVILBISS HEALTHCARE. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12011

12014

12015

12016

12018

12025

12026

FDA listed device types

showing 8 of 27

Cushion, Flotation 1Mattress, Flotation Therapy, Non-Powered 1Lift, Patient, Non-Ac-Powered 1Cane, Safety Walk 1Crutch 1Adaptor, Recreational 1Stand, Infusion 1Adult Portable Bed Rails For Medical Purposes 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
BR	10317709001	VÁLVULA ECONOMIZADORA DE O2	Class II
BR	10424969006	HUGO	Class I
BR	80026710013	ANDADOR TREINADOR DE MARCHA E LOCOMOÇÃO PARA PORTADORES DE DEFICIÊNCIA	Class I
CA	6418	DEVILBISS HEAVY DUTY AEREOSOL COMPRESSOR	Class II
CA	16184	DEVILBISS SERENITY MASK	Class II
CA	18167	DEVILBISS REUSABLE NEBULIZER	Class II

Drive DeVilbiss Healthcare

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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