Home›China›Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

✓ Record-verifiedregistrations found in 14 marketsEU SRN CN-MF-000014156Unified social credit code 914403007084678371

This company holds 892 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 13 overseas markets. EU UDI-DI records ≥13, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

892China registrations

Class I 118Class II 569Class III 205

as of 2026-09-04

EUEuropean UnionEUDAMED

≥13UDI-DI device records

Class IIa 2IVD A 5IVD B 1IVD C 5

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

USUnited StatesFDA openFDA

61listed device types

Class I 4Class II 57Class III 0

plus 257 registration records and 172 510(k)

UKUnited KingdomMHRA PARD

144registered device records

Class I 17Class IIa 44Class IIb 53Class III 4IVD A 7IVD B 11IVD C 3IVD general 5

BRBrazilANVISA

413registered devices

Class I 111Class II 302

498 including historic records

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

12active device licences

Class II 1Class III 11

81 including historic records

TWTaiwanTFDA

14valid device licences

Class II 12Class III 2

SGSingaporeHSA SMDR

33device registrations

CLASS B 22CLASS C 11

KRSouth KoreaMFDS GMP

10GMP quality-system certificates

Business type not stated 2Import 2IVD import 6

AUAustraliaTGA ARTG

106active ARTG entries

Class I 18Class III 5IVD Class 1 7IVD Class 2 14IIa 29IIb 33

HKHong KongMDACS

77valid listings

Class II 16Class III 30IVD B 23IVD C 8

ILIsraelAMAR

36registrations

RURussiaRoszdravnadzor

359active registrations

Class 1 6Class 2a 250Class 2b 87Class 3 16

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 Union7,656 raw hits, 87 excluded, 13 confirmed. Large result set — only the first 300 verified

United States257 registration records, 172 510(k), 0 PMA, 4 excluded

China892 certificates (Class III 205 / II 569 / I 118), as of 2026-09-04

United Kingdom144 confirmed, 2 excluded

Brazil413 confirmed, 8 excluded

Saudi Arabia7 confirmed, 3 excluded

Canada12 confirmed, 1 excluded

Manufacturer names merged into this page: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · Shenzhen Mindray Bio-Medical Electronics Co.,LTD · SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD · SHENZHEN MINDRAY BIO-MEDICAL ELETRONICS CO. · SHENZHEN MINDRAY BIO-MEDICAL ELETRONICS CO, LTD · SHENZEN MINDRAY BIO-MEDICAL ELETRONICS CO. LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000014156
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Mindray UK Limited
Unified social credit code: 914403007084678371
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1999-01-25
Registered capital: CNY 1,211,799,431
Paid-in capital: CNY 1,212,441,394
Legal form: Joint-stock limited company (HK/Macao/Taiwan and mainland joint venture, listed)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-08-28
Recognitions: National High-Tech EnterpriseManufacturing Single ChampionRecognised enterprise technology centreInnovative enterpriseChina Top 500 Private EnterpriseAbove-designated-size industrial enterprise
Listing: Listed on the A-share market

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

72007

82008

32009

72010

52011

72012

62013

72014

132015

82016

122017

82018

112019

102020

102021

92022

42023

72024

102025

62026

FDA listed device types

showing 8 of 61

Diluent, Blood Cell 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Products, Red-Cell Lysing Products 1Detergent 1System, Network And Communication, Physiological Monitors 1Counter, Differential Cell 1Detector And Alarm, Arrhythmia 1Index-Generating Electroencephalograph Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263401615	沙眼衣原体/淋球菌/解脲脲原体(CT/NG/UU)核酸质控品	Class III
CN	国械注准20263401476	弓形虫IgG抗体亲合力质控品	Class III
CN	国械注准20263401388	巨细胞病毒IgG抗体亲合力质控品	Class III
CN	国械注准20263400883	甲型肝炎病毒IgM抗体检测试剂盒（化学发光免疫分析法）	Class III
EU	06903053050913	4K 3D Video Endoscope	Class IIa
EU	06903053050951	4K 3D Video Endoscope	Class IIa
EU	06903053165594	Estriol (CLIA)	IVD B
EU	06903053037686	Neutralization Buffer	IVD A
UK	47769	Anesthesia Machine	Class IIb
UK	47769	Anesthesia System	Class IIb
UK	47769	Anesthesia System	Class IIb
US	K253330	A5 Anesthesia System (A5); A7 Anesthesia System (A7)	2026-06-25
US	K260098	ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)	2026-05-20
US	K260846	Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos	2026-05-11
BR	80115310347	Bilirubin Direct Kit (DSA Method)	Class II
BR	80115310348	Família Adenosine Deaminase	Class II
BR	80115310349	Apolipoprotein B Kit (Turbidimetry Method)	Class II
SA	ME0000000343SFDAA00009	Remote Imaging System	—
SA	ME0000009247SFDAA00001	Quik-Fil filling adapter for sevoflurane	—
CA	67511	PM-8000 PATIENT MONITOR	Class III
CA	70272	DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM	Class III
CA	71866	PM-50 PULSE OXIMETER	Class III