# Shenzhen Mindray Bio-Medical Electronics Co.,LTD (specification developer, SHENZHEN Guangdong, CN): 39 new FDA device listings, incl. detector and alarm, arrhythmia

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| Owner / operator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | SHENZHEN Guangdong, CN |
| New listings | 39 |
| Devices | Detector And Alarm, Arrhythmia; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Non-Normalizing Quantitative Electroencephalograph Software; Analyzer, Gas, Oxygen, Gaseous-Phase; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Stimulator, Nerve, Peripheral, Electric; Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); System, Measurement, Blood-Pressure, Non-Invasive; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Product codes | DSI, DRT, OLT, CCL, CCK, KOI, CBS, DXN, MHX, CBR, DSJ, CBQ, OLW, OMC, MLD |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Neurology, Anesthesiology, General Hospital, Radiology |
| Brand names | ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC); ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ); Anesthesia System(A5,A7,A4); Diagnostic Ultrasound System (MU7A); Diagnostic Ultrasound System (MU9 Exp); Diagnostic Ultrasound System (MU9 Pro); Diagnostic Ultrasound System (MU9 Super); Diagnostic Ultrasound System (MU7 Pro); Diagnostic Ultrasound System (MU7 Super); Diagnostic Ultrasound System (MU7P); Diagnostic Ultrasound System (MU9); Diagnostic Ultrasound System (MU9S); Diagnostic Ultrasound System (MU9T); Diagnostic Ultrasound System (MU9P); Diagnostic Ultrasound System (MU9A); Diagnostic Ultrasound System (MU7) |
| First new listing | 2026-05-25 |
| Latest new listing | 2026-08-17 |
| FDA registration number | 3007603826 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

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.