Data / Medical devices / China / Cathwide Medical Co.,ltd.
Cathwide Medical Co.,ltd.: FDA-registered device maker in Shanghai, China, 3 510(k) clearances
Cathwide Medical Co.,ltd. is registered with the FDA (registration 3031175043) in Shanghai, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated April 8, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031175043
- Address
- 305A Building 9 No. 1888 Xinjinqiao Road, Shanghai, China, 201206
- Owner or operator
- Cathwide Medical Co.,Ltd. (10092546)
- Roles
- Exporter to the US
- First device listed
- January 18, 2025
- Registered through
- 2026
- Brand names listed
- All Silicone Foley Catheter with Temperature Sensor, Disposable silicone Foley catheter, Latex Foley Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 8, 2021 | K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | EZL | Substantially Equivalent | Well Lead Medical Co., Ltd. | accessdata.fda.gov |
| July 13, 2018 | K173340 | Yikang Latex Foley Catheter | EZL | Substantially Equivalent | Jiangxi Yikang Medical Instrument Group Co., Ltd. | accessdata.fda.gov |
| October 3, 2013 | K130908 | DISPOSABLE SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | Guangdong Baihe Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 8, 2021. 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.