Data / Medical devices / Hysteroscope (And Accessories) / China
FDA-registered makers of Hysteroscope (And Accessories) in China: 11 establishments
11 establishments in China are registered with the FDA to make Hysteroscope (And Accessories) (product code HIH). 6 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
- Hysteroscope (And Accessories)
- Product code
- HIH
- Country
- China
Makers of Hysteroscope (And Accessories) in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Suzhou Acuvu Medical Technology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 3 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Red Pine Medical Instrument Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 2 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou Jiangsu, China | Complaint file establishment, Manufacturer, Specification developer | 2 | December 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Macrolux Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | August 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Origyn Medical Technology (hangzhou) Co., Ltd | Hangzhou Zhejiang, China | Manufacturer, Specification developer | 1 | July 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shanghai AnQing Medical Instrument Co., Ltd | Shanghai, China | Exporter to the US, Manufacturer | 1 | February 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Skonsin Electronics Ltd. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peter's Technology (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao O-Mec Medical Technology Co., Ltd. | Qingdao Shandong, 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.