Contract manufacturerMINDRAY DS USA, Inc. (Mahwah, NJ)New JerseyAnesthesiologyCardiovascularGeneral hospitalGeneral and plastic surgeryNeurologyRadiologyHematologyClass IIClass I
MINDRAY DS USA, Inc.
Contract manufacturer ยท Mahwah, NJ
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- 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 code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| CAD | Vaporizer, Anesthesia, Non-Heated | Class II | Anesthesiology | Contract manufacturing | Aug 4, 2015 |
| CBK | Ventilator, Continuous, Facility Use | Class II | Anesthesiology | Contract manufacturing | Dec 8, 2025 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| DPZ | Oximeter, Ear | Class II | Cardiovascular | Contract manufacturing | Sep 2, 2026 |
| DQA | Oximeter | Class II | Cardiovascular | Contract manufacturing | Dec 12, 2019 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | Class II | Cardiovascular | Contract manufacturing | Jun 1, 2026 |
| DRS | Transducer, Blood-Pressure, Extravascular | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class II | Cardiovascular | Contract manufacturing | Dec 12, 2019 |
| DSB | Plethysmograph, Impedance | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| DSI | Detector And Alarm, Arrhythmia | Class II | Cardiovascular | Contract manufacturing | Dec 12, 2019 |
| DSJ | Alarm, Blood-Pressure | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| DSK | Computer, Blood-Pressure | Class II | Cardiovascular | Contract manufacturing | Dec 12, 2019 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | Contract manufacturing | Dec 12, 2019 |
| FLL | Continuous Measurement Thermometer | Class II | General hospital | Contract manufacturing | Dec 12, 2019 |
| FQO | Table, Operating-Room, Ac-Powered | Class I | General and plastic surgery | Contract manufacturing | Nov 12, 2024 |
| GXY | Electrode, Cutaneous | Class II | Neurology | Contract manufacturing | May 11, 2023 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract manufacturing | Dec 12, 2019 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | Contract manufacturing | Dec 12, 2019 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract manufacturing | Dec 12, 2019 |
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | Class I | General and plastic surgery | Contract manufacturing | Nov 12, 2024 |
| KDP | Regulator, Vacuum | Class II | General hospital | Contract manufacturing | Feb 8, 2018 |
| KOI | Stimulator, Nerve, Peripheral, Electric | Class II | Anesthesiology | Contract manufacturing | May 11, 2023 |
| KRC | Tester, Electrode, Surface, Electrocardiographic | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| KRX | Calibrator For Cell Indices | Class II | Hematology | Contract manufacturing | Jun 14, 2023 |
| KRY | Calibrator For Platelet Counting | Class II | Hematology | Contract manufacturing | Jun 14, 2023 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | Class II | Hematology | Contract manufacturing | Jun 14, 2023 |
| KSA | Calibrator For Red-Cell And White-Cell Counting | Class II | Hematology | Contract manufacturing | Jun 14, 2023 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Jan 8, 2018 |
| MLC | Monitor, St Segment | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| MLD | Monitor, St Segment With Alarm | Class II | Cardiovascular | Contract manufacturing | Dec 12, 2019 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | Class II | Anesthesiology | Contract manufacturing | Jun 1, 2026 |
| MSX | System, Network And Communication, Physiological Monitors | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| MUD | Oximeter, Tissue Saturation | Class II | Cardiovascular | Contract manufacturing | May 11, 2023 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Jun 9, 2023 |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Class II | Anesthesiology | Contract manufacturing | Feb 25, 2013 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | Class II | Neurology | Contract manufacturing | May 11, 2023 |
| OLW | Index-Generating Electroencephalograph Software | Class II | Neurology | Contract manufacturing | May 11, 2023 |
| OMC | Reduced- Montage Standard Electroencephalograph | Class II | Neurology | Contract manufacturing | May 11, 2023 |
| ORT | Burst Suppression Detection Software For Electroencephalograph | Class II | Neurology | Contract manufacturing | May 11, 2023 |