DeviceEstablishmentPulse / report
Shenzhen Mindray Bio-Medical Electronics Co.,LTD (specification developer, SHENZHEN Guangdong, CN): 39 new FDA device listings, incl. detector and alarm, arrhythmia
Shenzhen Mindray Bio-Medical Electronics Co.,LTD (SHENZHEN Guangdong): 39 new FDA device listings, incl. detector and alarm, arrhythmia. Its amount of 39 is top-decile (99th percentile of 2,570 records). Dated 79 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 39 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 39.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 99th of 2,570 (median 1, 39.0x median) |
| Peer records CSV (500 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-17
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Shenzhen Mindray Bio-Medical Electronics Co.,LTD and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Shenzhen Mindray Bio-Medical Electronics Co.,LTD's amount: 99th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 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.
What is the DeviceEstablishmentPulse record for Shenzhen Mindray Bio-Medical Electronics Co.,LTD in SHENZHEN Guangdong?
Shenzhen Mindray Bio-Medical Electronics Co.,LTD (SHENZHEN Guangdong, CN), a specification developer (outsources manufacturing), added 39 FDA device listings between 2026-05-25 and 2026-08-17.
How does Shenzhen Mindray Bio-Medical Electronics Co.,LTD compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 39 is 39.0x the median of 1 across 2,570 records. It is 79 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Shenzhen Mindray Bio-Medical Electronics Co.,LTD vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, CN | 39 | 99th | 2026-08-17 |
| Arthrex, Inc. | Naples, FL | 12 | 95th | 2026-09-27 |
| Boston Scientific Corporation | Marlborough, MA | 9 | 92nd | 2026-10-16 |
| Sol-Millennium Medical, Inc. | Chicago, IL | 8 | 91st | 2026-09-28 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: Foreign establishment
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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.