Data / Medical devices / Catheter, Retention Type, Balloon / China
FDA-registered makers of Catheter, Retention Type, Balloon in China: 15 establishments
15 establishments in China are registered with the FDA to make Catheter, Retention Type, Balloon (product code EZL). 8 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
- Catheter, Retention Type, Balloon
- Product code
- EZL
- Country
- China
Makers of Catheter, Retention Type, Balloon in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer, Manufacturer | 4 | September 13, 2010 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Primecare Medical Co.,Ltd. | hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 3 | January 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer | 2 | April 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer | 2 | April 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Manufacturer | 1 | September 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd | Jintan Jiangsu, China | Manufacturer | 1 | June 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Baihe Medical Technology Co., Ltd | Foshan Guangdong, China | Exporter to the US, Manufacturer | 1 | October 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | Nanchang Jiangxi, China | Manufacturer | 1 | July 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bioxin Medical Co., Ltd | Weihai Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Bao Kang Dian Zi Ke Ji Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haiyan Kangyuan Medical Instrument Co.,ltd. | JiaXing Zhejiang, 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 | |
| Primecare Medical (Huzhou) Co.,Ltd. | Hu zhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primecare Medical (Suzhou) Co.,Ltd. | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical (hainan) Co., Ltd. | Haikou Hainan, China | Contract manufacturer, 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.