Data / Medical devices / Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) / China
FDA-registered makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) in China: 10 establishments
10 establishments in China are registered with the FDA to make Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX). 9 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Product code
- MHX
- Country
- China
Makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 18 | May 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 16 | August 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer, Specification developer | 14 | May 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer, Specification developer | 5 | July 24, 2026 | 0 | 1 | 0 | api.fda.gov |
| Guangdong Biolight Meditech Co., Ltd | Zhuhai Guangdong, China | Manufacturer | 5 | February 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 3 | December 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai, China | Specification developer | 2 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Contec Medical Systems Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 1 | June 28, 2011 | 0 | 1 | 0 | api.fda.gov |
| General Meditech, Inc. | Shenzhen Guangdong, China | Manufacturer | 1 | February 2, 2010 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.