# MINDRAY DS USA, Inc. (contract manufacturer, Mahwah, NJ): 62 new FDA device listings, incl. continuous, minimal ventilatory support, facility use ventilator

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | MINDRAY DS USA, Inc. |
| Owner / operator | Mindray DS USA, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Mahwah, NJ, US |
| New listings | 62 |
| Devices | Continuous, Minimal Ventilatory Support, Facility Use Ventilator; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Amplifier And Signal Conditioner, Transducer Signal; System, Network And Communication, Physiological Monitors; Plethysmograph, Impedance; Oximeter; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); System, Measurement, Blood-Pressure, Non-Invasive; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Burst Suppression Detection Software For Electroencephalograph |
| Product codes | MNT, DRT, DRQ, MSX, DSB, DQA, MHX, DXN, CCK, ORT, DSJ, OLW, CCL, KOI, GXY |
| Device classes | Class II |
| Medical specialties | Anesthesiology, Cardiovascular, Neurology, General Hospital, Radiology |
| Brand names | SV70 Ventilator; BeneVision Distributed Monitoring System (DMS) with Telemetry TM80, TM70; BeneVision Central Monitoring System (CMS) with Telemetry TMS60, TM80, TM70; ePM 10M Monitor; ePM 10A Monitor; ePM 12M Monitor; ePM Series Monitor; ePM 12MA Monitor |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-09-02 |
| FDA registration number | 2221819 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.