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MINDRAY DS USA, Inc.

USA · Mahwah

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

59listed device types

Class I 6Class II 53Class III 0

plus 71 registration records and 3 510(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

31active device licences

Class II 13Class III 18

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 States71 registration records, 3 510(k), 0 PMA, 9 excluded

Brazil0 confirmed, 14 excluded

Saudi Arabia0 confirmed, 8 excluded

Canada31 confirmed, 1 excluded

Manufacturer names merged into this page: MINDRAY DS USA, Inc. · MINDRAY DS USA, INC.

FDA 510(k) clearances by year

12010 · K102004

12011 · K102471

12013 · K132026

FDA listed device types

showing 8 of 59

System, Network And Communication, Physiological Monitors 1Counter, Differential Cell 1Detector And Alarm, Arrhythmia 1Index-Generating Electroencephalograph Software 1Amplifier And Signal Conditioner, Transducer Signal 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Electrode, Ion-Specific, Chloride 1Analyzer, Gas, Oxygen, Gaseous-Phase 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K132026	V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21	2013-12-20
US	K102471	AS3700 ANESTHSIA DELIVERY SYSTEM	2011-02-11
US	K102004	ENDEAVOUR MONITORING SYSTEM	2010-09-10
CA	1442	GAS MODULE 3	Class III
CA	2544	VISA CENTRAL STATION	Class III
CA	15125	PASSPORT MONITOR WITH DFIB OPTION	Class III

MINDRAY DS USA, 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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