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Inovo, Inc.

USA · Lehigh Acres

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia — 5 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 14 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

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, 6 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Inovo Inc. · INOVO, INC.

FDA 510(k) clearances by year

12003 · K031983

12005 · K051540

12006 · K060751

12010 · K103392

12011 · K113111

12014 · K141967

FDA listed device types

showing 8 of 9

Holding Chambers, Direct Patient Interface 1Bottle, Collection, Vacuum 1Bed, Ac-Powered Adjustable Hospital 1Conserver, Oxygen 1Lift, Patient, Ac-Powered 1Adaptor, Recreational 1Adaptor, Hygiene 1Regulator, Pressure, Gas Cylinder 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141967	PUREFILL OXYGEN COMPRESSOR	2014-11-07
US	K113111	CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION	2011-12-08
US	K103392	CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER	2010-12-17
CA	91220	SMARTDOSE LIQUID OXYGEN PORTABLES	Class II

Inovo, 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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