Data / Medical devices / System, Monitoring, Perinatal / China
FDA-registered makers of System, Monitoring, Perinatal in China: 6 establishments
6 establishments in China are registered with the FDA to make System, Monitoring, Perinatal (product code HGM). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Monitoring, Perinatal
- Product code
- HGM
- Country
- China
Makers of System, Monitoring, Perinatal in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 5 | August 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| China Qingdao Bright Medical Manufacturing Co.,ltd. | Qingdao Shandong, China | Exporter to the US, Manufacturer | 1 | August 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Specification developer | 1 | June 21, 2005 | 0 | 0 | 0 | api.fda.gov |
| Orantech Inc. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 1 | November 25, 2014 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LUEN HING TEXTILE -Shangyu Manufacturing(ZHONG SHAN) CO LTD | Zhongshan 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.