MedtechSourcebook

MINDRAY DS USA, Inc.

Contract manufacturer ยท Mahwah, NJ

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2013Product codes first listed, by year (tallest: 20)2026
FDA registration
2221819 (openFDA record; or search FDA's registration database)
FEI number
2221819
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Contract manufacturer
Owner or operator
Mindray DS USA, Inc. (FDA owner/operator no. 10025908)
Registered address
800 MACARTHUR BLVD., Mahwah, NJ 07430
Contract listings
39 device listings, 48 product codes, first listed Feb 25, 2013
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
BSZGas-Machine, AnesthesiaClass IIAnesthesiologyContract manufacturingFeb 25, 2013
CADVaporizer, Anesthesia, Non-HeatedClass IIAnesthesiologyContract manufacturingAug 4, 2015
CBKVentilator, Continuous, Facility UseClass IIAnesthesiologyContract manufacturingDec 8, 2025
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Class IIAnesthesiologyContract manufacturingFeb 25, 2013
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Class IIAnesthesiologyContract manufacturingFeb 25, 2013
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Class IIAnesthesiologyContract manufacturingFeb 25, 2013
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass IIAnesthesiologyContract manufacturingFeb 25, 2013
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseClass IIAnesthesiologyContract manufacturingFeb 25, 2013
DPZOximeter, EarClass IICardiovascularContract manufacturingSep 2, 2026
DQAOximeterClass IICardiovascularContract manufacturingDec 12, 2019
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyClass IICardiovascularContract manufacturingMay 11, 2023
DRQAmplifier And Signal Conditioner, Transducer SignalClass IICardiovascularContract manufacturingJun 1, 2026
DRSTransducer, Blood-Pressure, ExtravascularClass IICardiovascularContract manufacturingMay 11, 2023
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Class IICardiovascularContract manufacturingDec 12, 2019
DSBPlethysmograph, ImpedanceClass IICardiovascularContract manufacturingMay 11, 2023
DSIDetector And Alarm, ArrhythmiaClass IICardiovascularContract manufacturingDec 12, 2019
DSJAlarm, Blood-PressureClass IICardiovascularContract manufacturingMay 11, 2023
DSKComputer, Blood-PressureClass IICardiovascularContract manufacturingDec 12, 2019
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionClass IICardiovascularContract manufacturingMay 11, 2023
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveClass IICardiovascularContract manufacturingDec 12, 2019
FLLContinuous Measurement ThermometerClass IIGeneral hospitalContract manufacturingDec 12, 2019
FQOTable, Operating-Room, Ac-PoweredClass IGeneral and plastic surgeryContract manufacturingNov 12, 2024
GXYElectrode, CutaneousClass IINeurologyContract manufacturingMay 11, 2023
ITXTransducer, Ultrasonic, DiagnosticClass IIRadiologyContract manufacturingDec 12, 2019
IYNSystem, Imaging, Pulsed Doppler, UltrasonicClass IIRadiologyContract manufacturingDec 12, 2019
IYOSystem, Imaging, Pulsed Echo, UltrasonicClass IIRadiologyContract manufacturingDec 12, 2019
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredClass IGeneral and plastic surgeryContract manufacturingNov 12, 2024
KDPRegulator, VacuumClass IIGeneral hospitalContract manufacturingFeb 8, 2018
KOIStimulator, Nerve, Peripheral, ElectricClass IIAnesthesiologyContract manufacturingMay 11, 2023
KRCTester, Electrode, Surface, ElectrocardiographicClass IICardiovascularContract manufacturingMay 11, 2023
KRXCalibrator For Cell IndicesClass IIHematologyContract manufacturingJun 14, 2023
KRYCalibrator For Platelet CountingClass IIHematologyContract manufacturingJun 14, 2023
KRZCalibrator For Hemoglobin And Hematocrit MeasurementClass IIHematologyContract manufacturingJun 14, 2023
KSACalibrator For Red-Cell And White-Cell CountingClass IIHematologyContract manufacturingJun 14, 2023
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Class IICardiovascularContract manufacturingJan 8, 2018
MLCMonitor, St SegmentClass IICardiovascularContract manufacturingMay 11, 2023
MLDMonitor, St Segment With AlarmClass IICardiovascularContract manufacturingDec 12, 2019
MNTContinuous, Minimal Ventilatory Support, Facility Use VentilatorClass IIAnesthesiologyContract manufacturingJun 1, 2026
MSXSystem, Network And Communication, Physiological MonitorsClass IICardiovascularContract manufacturingMay 11, 2023
MUDOximeter, Tissue SaturationClass IICardiovascularContract manufacturingMay 11, 2023
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Class IICardiovascularContract manufacturingJun 9, 2023
NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)Class IIAnesthesiologyContract manufacturingFeb 25, 2013
NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)Class IIAnesthesiologyContract manufacturingFeb 25, 2013
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)Class IIAnesthesiologyContract manufacturingFeb 25, 2013
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareClass IINeurologyContract manufacturingMay 11, 2023
OLWIndex-Generating Electroencephalograph SoftwareClass IINeurologyContract manufacturingMay 11, 2023
OMCReduced- Montage Standard ElectroencephalographClass IINeurologyContract manufacturingMay 11, 2023
ORTBurst Suppression Detection Software For ElectroencephalographClass IINeurologyContract manufacturingMay 11, 2023