Data / Medical devices / Ureteroscope And Accessories, Flexible/Rigid / China
FDA-registered makers of Ureteroscope And Accessories, Flexible/Rigid in China: 17 establishments
17 establishments in China are registered with the FDA to make Ureteroscope And Accessories, Flexible/Rigid (product code FGB). 14 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
- Ureteroscope And Accessories, Flexible/Rigid
- Product code
- FGB
- Country
- China
Makers of Ureteroscope And Accessories, Flexible/Rigid in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Shanghai AnQing Medical Instrument Co., Ltd | Shanghai, China | Exporter to the US, Manufacturer | 6 | October 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hunan Vathin Medical Instrument Co., Ltd. | Xiangtan Hunan, China | Manufacturer | 4 | May 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Red Pine Medical Instrument Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 3 | September 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Macrolux Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | July 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Scivita Medical Technology Co., Ltd. | suzhou Jiangsu, China | Manufacturer | 2 | August 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 2 | July 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dongguan ZSR Biomedical Technology Company Limited | Dongguan Guangdong, China | Manufacturer | 1 | February 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hunan Endoso Life Technology Co., Ltd | XiangTan Hunan, China | Manufacturer | 1 | January 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Seplou (zhuhai) Co.,ltd. | Zhuhai Guangdong, China | Manufacturer | 1 | August 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Seegen Photoelectric Technology Co., Ltd | Shanghai, China | Manufacturer | 1 | February 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Seegen Photoelectric Technology Co., Ltd | Shanghai, China | Manufacturer | 1 | February 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Besdata Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 1 | October 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | May 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Sanping Image Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | October 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Wise Optomech Technology Corporation | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgnova Healthcare Technologies (zhejiang) Co., Ltd. | Cixi Zhejiang, China | 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.