Data / Medical devices / Cystoscope And Accessories, Flexible/Rigid / China
FDA-registered makers of Cystoscope And Accessories, Flexible/Rigid in China: 12 establishments
12 establishments in China are registered with the FDA to make Cystoscope And Accessories, Flexible/Rigid (product code FAJ). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Cystoscope And Accessories, Flexible/Rigid
- Product code
- FAJ
- Country
- China
Makers of Cystoscope And Accessories, Flexible/Rigid in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Guangzhou Red Pine Medical Instrument Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 3 | August 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hunan Vathin Medical Instrument Co., Ltd. | Xiangtan Hunan, China | Exporter to the US, Manufacturer | 2 | December 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shanghai AnQing Medical Instrument Co., Ltd | Shanghai, China | Exporter to the US, Manufacturer | 2 | September 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Macrolux Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | June 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | November 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Tiansong Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 1 | May 5, 1997 | 0 | 0 | 0 | api.fda.gov |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 1 | September 26, 2022 | 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 | |
| Qingdao O-Mec Medical Technology Co., Ltd. | Qingdao Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scivita Medical Technology Co., Ltd. | suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, 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.