BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MINDRAY DS USA, Inc.

    Reg #: 2221819 · FEI: 2221819 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    123
    Establishment Types
    2
    Classifications
    59

    Registration Details

    Registration Name
    MINDRAY DS USA, Inc.
    Registration Number
    2221819
    FEI Number
    2221819
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    800 MACARTHUR BLVD.
    City
    Mahwah
    State
    NJ
    ZIP
    07430
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200251

    Owner / Operator

    Firm Name
    Mindray DS USA, Inc.
    Operator Number
    10025908
    Address
    800 MacArthur Blvd
    City
    Mahwah
    State
    NJ
    Postal Code
    07430
    Country
    US
    Correspondent
    James Clifford

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Counter, Differential Cell GKZ
    Table, Operating-Room, Ac-Powered FQO
    Regulator, Vacuum KDP
    Gas-Machine, Anesthesia BSZ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Calibrator For Red-Cell And White-Cell Counting KSA
    Calibrator For Platelet Counting KRY
    Calibrator For Hemoglobin And Hematocrit Measurement KRZ
    Calibrator For Cell Indices KRX
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Continuous Measurement Thermometer FLL
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Oximeter DQA
    Mixture, Hematology Quality Control JPK
    Monitor, St Segment With Alarm MLD
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Detector And Alarm, Arrhythmia DSI
    Computer, Blood-Pressure DSK
    Electrode, Ion Specific, Potassium CEM
    Hexokinase, Glucose CFR
    Electrode, Ion-Specific, Chloride CGZ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion Specific, Sodium JGS
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    System, Image Processing, Radiological LLZ
    Products, Red-Cell Lysing Products GGK
    Ventilator, Continuous, Facility Use CBK
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Detergent JCB
    Sv70 Ventilator MNT
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    System, Network And Communication, Physiological Monitors MSX
    Plethysmograph, Impedance DSB
    Diluent, Blood Cell GIF
    Table, Surgical With Orthopedic Accessories, Ac-Powered JEA
    Alarm, Blood-Pressure DSJ
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Transducer, Blood-Pressure, Extravascular DRS
    Stimulator, Nerve, Peripheral, Electric KOI
    Burst Suppression Detection Software For Electroencephalograph ORT
    Index-Generating Electroencephalograph Software OLW
    Electrode, Cutaneous GXY
    Tester, Electrode, Surface, Electrocardiographic KRC
    Oximeter, Tissue Saturation MUD
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Reduced- Montage Standard Electroencephalograph OMC
    Monitor, St Segment MLC
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Vaporizer, Anesthesia, Non-Heated CAD

    Proprietary Names

    Z5 Diagnostic Ultrasound System BC3200 Hematology Analyzer TE Air Diagnostic Ultrasound System HyBase V6 Operating Table HyBase V6 Operation Table accessories V90 Electronic Vaporizers A8 Anesthesia Delivery System A9 Anesthesia Delivery System DC-3 Ultrasound System SC-CAL Plus Calibrator Accutorr 7 Rosie 4 BC-5390 Auto Hematology Analyzer MX7 Diagnostic Ultrasound System MX8 Diagnostic Ultrasound System ME8 Diagnostic Ultrasound System BC-3D control DP-20 Digital Ultrasonic Diagnostic Imaging System DP-30 Digital Ultrasonic Diagnostic Imaging System Passport Series Patient Monitor, 12m, 17m and T1 BS-400/CLC 720 Chemistry Analyzer Accutorr 3 Monitor Rosebud M6 Ultrasound System Imagyn I9 Diagnostic Ultrasound System Resona I9T Diagnostic Ultrasound System Resona I9 Diagnostic Ultrasound System BS-480 Chemistry Analyzer Yumizen C560 Chemistry Analyzer CLC720i Chemistry Analyzer DC-8 Diagnostic Ultrasound System DC-8 EXP Diagnostic Ultrasound System BA-800M Chemistry Analyzer BA-800M ISE KIT Chemistry Analyzer Z60 Diagnostic Ultrasound System Z6 Diagnostic Ultrasound System M-5LEO(I) LYSE M-5LEO(II) LYSE M-53LH LYSE M-30CFL LYSE Passport 8/12 Monitor cPM 8/12 DC-88 Diagnostic Ultrasound System DC-90 Diagnostic Ultrasound System DC-80 Diagnostic Ultrasound System ViewMate Ultrasound System SV900 Ventilator SV700 Ventilator DP-6900 ZS3 Elite Ultrasound Systems Z.one pro Ultrasound System ZS3KP Elite Ultrasound Systems DC-T6 Ultrasound System Resona A20 Diagnostic Ultrasound System ViewMate Multi Ultrasound System (VMM-ICE-01) ViewMate Multi Ultrasound System (VMM-ICE-02) Resona I8 Diagnostic Ultrasound System Hepatus 5 Diagnostic Ultrasound System Hepatus 6 Diagnostic Ultrasound System A7 Anesthesia System M7 Diagnostic Ultrasound System A3 Anesthesia Delivery System A5 Anesthesia Delivery System PROBE CLEANSER M-30R RINSE M-30P PROBE CLEANSER M-30 E-Z CLEANSER SV70 Ventilator Consona N6 Diagnostic Ultrasound System A5 Anesthesia System A4 Anesthesia System Consona N9 Diagnostic Ultrasound System TE X Diagnostic Ultrasound System TE X Lite Diagnostic Ultrasound System BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70 BeneVision Distributed Monitoring System (DMS) with Telemetry TM80, TM70 BeneVision Central Monitoring System with Telemetry - TD60 and TM80, and accessories VS-900c Fukuda VSM Vital Signs Monitors VS 8 Vital Signs Monitors VS 9 Vital Signs Monitors VS 8A M-53D Diluent M-30D Diluent BS200 Chemistry Analyzer Pointe c2000 Chemistry Analyzer HyBase V6 Operating Table Accessories(Orthopaedic Extension Device kit-CF, Orthopaedic Extension Device kit) Operating Room Accessories Table Tray HyBase V6 Operating Table (Orthopaedic Extension Device kit-CF, Orthopaedic Extension Device kit) ViewMate Multi Ultrasound System MX3 Diagnostic Ultrasound System MX6 Diagnostic Ultrasound System DC-40 Diagnostic Ultrasound System TE7 / TE5 / TE7 Max / TE9 Ultrasound System DP-50 Expert Digital Ultrasonic Diagnostic Imaging System ePM Series Monitor ePM 10A Monitor ePM 12M Monitor ePM 12MA Monitor ePM 10M Monitor ePM 15M Monitor M9 Diagnostic Ultrasound System M9 Premium Diagnostic Ultrasound System M8 Elite Diagnostic Ultrasound System BeneVision N1 Patient Monitor BeneVision N19 Patient Monitor BeneVision N17 Patient Monitor BeneVision N15 Patient Monitor BeneVision N22 Patient Monitor BeneVision N12 Patient Monitor BeneVision N Series Patient Monitor DC-70 Diagnostic Ultrasound System Vapor 2000 SERVO Vapor 2000 ISO ACUSON Bonsai Diagnostic Ultrasound System BC-5D hematology control D-Vapor DES V60 Anesthetic Vaporizer DC-N3 Diagnostic Ultrasound System M5 Ultrasound System DC-7 Ultrasound System BC-3600 Auto Hematology Analyzer Resona 7 Diagnostic Ultrasound System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)