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Omron Healthcare Brasil Industria e Comercio de Produtos Medicos Ltda

Brazil

✓ Record-verifiedregistrations found in 4 markets

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

17listed device types

Class I 3Class II 14Class III 0

plus 75 registration records and 68 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

32registered devices

Class I 1Class II 31

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

11active device licences

Class II 4Class III 7

31 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 States75 registration records, 68 510(k), 0 PMA, 6 excluded

Brazil32 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: Omron Healthcare, Inc. · OMRON HEALTHCARE CO., LTD. · OMRON HEALTHCARE INC. · Omron Healthcare Brasil Industria e Comercio de Produtos Medicos Ltda · OMRON HEALTHCARE BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS MÉDICOS LTDA · OMRON Healthcare Co., Ltd.

FDA 510(k) clearances by year

11997

32000

12001

12002

22004

72005

42006

32007

32008

12009

32011

32012

32013

52014

22016

32017

42018

42019

12021

12024

FDA listed device types

showing 8 of 17

Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Analyzer, Body Composition, Exempt 1System, Measurement, Blood-Pressure, Non-Invasive 1Meter, Peak Flow, Spirometry 1Electrode, Cutaneous 1Transmitters And Receivers, Electrocardiograph, Telephone 1Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature 1Nebulizer (Direct Patient Interface) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	DEN230076	Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))	2024-10-08
US	K202228	Omron Model BP7900 Blood Pressure Monitor + EKG	2021-04-01
US	K183215	Focus TENS Therapy, Model PM710-M/-L	2019-09-07
BR	81952079016	Monitor de Pressão Arterial de Braço	Class II
BR	81952079017	Monitor de Pressão Arterial de Braço	Class II
BR	81952079003	MONITOR DE PRESSÃO ARTERIAL DE BRAÇO AUTOMÁTICO	Class II
SA	ME0000005433SFDAA00021	AC Adapter	—
CA	17690	PULSE MASSAGER	Class II
CA	17700	VIBRATING MASSAGER	Class II
CA	17705	GENTLE TOUCH INSTANT EAR THERMOMETER	Class II

Omron Healthcare Brasil Industria e Comercio de Produtos Medicos Ltda

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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