Data / Medical devices / Electrocardiograph / China
FDA-registered makers of Electrocardiograph in China: 17 establishments
17 establishments in China are registered with the FDA to make Electrocardiograph (product code DPS). 8 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Electrocardiograph
- Product code
- DPS
- Country
- China
Makers of Electrocardiograph in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 11 | July 2, 2026 | 0 | 1 | 0 | api.fda.gov |
| Contec Medical Systems Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 4 | January 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC | Shanghai, China | Specification developer | 4 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer, Specification developer | 3 | January 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 3 | January 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing, China | Exporter to the US, Manufacturer | 2 | July 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Biolight Meditech Co., Ltd | Zhuhai Guangdong, China | Manufacturer | 1 | June 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | April 25, 2012 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omron (dalian) Co., Ltd. (plant 1) | DALIAN Liaoning, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Regent Electron Suzhou Co., Ltd | Wujiang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ryder Electronics (shenzhen) Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Viatom Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Strong Electronics | Wuhan Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yahorng Dongguan Electronic Co Ltd | 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.