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OMRON HEALTHCARE (CHINA) CO., LTD.

China · 上海

✓ Record-verifiedregistrations found in 12 marketsEU SRN JP-MF-000007213Unified social credit code 91210200726008108G

This company holds 3 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 11 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

3China registrations

Class II 3

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 75Class IIa 225

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

17listed device types

Class I 3Class II 14Class III 0

plus 75 registration records and 68 510(k)

UKUnited KingdomMHRA PARD

20registered device records

Class I 6Class IIa 14

BRBrazilANVISA

28registered devices

Class I 1Class II 27

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

15valid device licences

Class I 1Class II 14

SGSingaporeHSA SMDR

50device registrations

CLASS B 50

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 3IIa 8

HKHong KongMDACS

13valid listings

Class II 13

ILIsraelAMAR

2registrations

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.

European Union333 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

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

China3 certificates (Class III 0 / II 3 / I 0), as of 2026-09-04

United Kingdom20 confirmed, 0 excluded

Brazil28 confirmed, 2 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 Co., Ltd.

Regulatory identity

EU manufacturer SRN: JP-MF-000007213
EU authorised representative: OMRON Healthcare Europe B.V.
UK responsible person: OMRON Healthcare UK Ltd.
Unified social credit code: 91210200726008108G
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2001-03-13
Registered capital: USD 28,900,000
Paid-in capital: USD 28,900,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Wholesale trade
Last approval date: 2026-07-20
Recognitions: Micro and small enterpriseAbove-designated-size industrial enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

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
CN	辽械注准20252210155	心电分析提示软件	Class II
CN	辽械注准20252210113	脉搏波房颤提示软件	Class II
CN	辽械注准20242210026	心电分析提示软件	Class II
EU	04015672114647	M2 Comfort (HEM-7188-FLD6)	Class IIa
EU	04975479498411	—	Class IIa
EU	04975479499500	—	Class IIa
EU	04975479496516	—	Class I
UK	66295	OMRON Nebulizers	Class IIa
UK	16173	Boots Electronic Sphygmomanometers	Class IIa
UK	16173	OMRON Electronic Sphygmomanometers	Class IIa
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