Data / Medical devices / Endoscopic Access Overtube, Gastroenterology-Urology / China
FDA-registered makers of Endoscopic Access Overtube, Gastroenterology-Urology in China: 15 establishments
15 establishments in China are registered with the FDA to make Endoscopic Access Overtube, Gastroenterology-Urology (product code FED). 13 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Endoscopic Access Overtube, Gastroenterology-Urology
- Product code
- FED
- Country
- China
Makers of Endoscopic Access Overtube, Gastroenterology-Urology in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hunan Vathin Medical Instrument Co., Ltd. | Xiangtan Hunan, China | Manufacturer | 2 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 2 | December 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 2 | September 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Dongguan ZSR Biomedical Technology Company Limited | Dongguan Guangdong, China | Manufacturer | 1 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Innovex Medical Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 1 | January 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Macrolux Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | June 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 1 | March 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 1 | March 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Seplou (zhuhai) Co.,ltd. | Zhuhai Guangdong, China | Manufacturer | 1 | January 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | July 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Trious Medical Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | April 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Yigao Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 1 | September 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 1 | April 6, 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 | |
| Sumitomo Bakelite (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.