HomeChinaNANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

China · Nanjing Jiangsu
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
19registered devices
Class I 15Class II 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
12valid device licences
Class I 5Class II 7
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
13active ARTG entries
Class I 8IIa 4IIb 1
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
14active registrations
Class 1 4Class 2a 10
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 States2 registration records, 2 510(k), 0 PMA, 9 excluded
Brazil19 confirmed, 12 excluded
Saudi Arabia8 confirmed, 5 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD · NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTDA · Nanjing Mindray Bio-Medical Electronics Co.Ltd · Nanjing Mindray Bio-Medical Electronics Co., Ltd. · NANJING MINDRAY BIO-MEDIACAL ELECTRONICS CO.,LTD

Company information

Country
China
City
Nanjing Jiangsu

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12015 · K143348
12016 · K160429

FDA listed device types

Table, Surgical With Orthopedic Accessories, Ac-Powered 1Table, Operating-Room, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK160429BC-5390 Auto Hematology Analyzer2016-09-01
USK143348BC-3600 Auto Hematology Analyzer2015-08-21
BR80943610315Foco Cirúrgico HyLED QClass I
BR80943610316Mesa de operaçãoClass I
BR80943610321Mesa de operaçãoClass I
SAME0000000836SFDAA00001LED Examination Light
SAME0000000235SFDAA00001Mindray

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