Cathwide Medical Co., Ltd.
Registered establishment in Shanghai, China. 1 device type.
Cathwide Medical Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Catheter, Retention Type, Balloon. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | CATHWIDE MEDICAL CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031175043 |
| FEI number | 3031175043 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 珂德醫療(香港)有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 305A Building 9 |
| Postal code | 201206 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | Class 2 | All Silicone Foley Catheter with Temperature Sensor, Disposable silicone Foley catheter, Latex Foley Catheter | 2025 | 17 |
Clearances
No clearance names Cathwide Medical Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K202134 | 2021-04-08 | EZL | Special | Well Lead Medical Co., Ltd. |
| K173340 | 2018-07-13 | EZL | Traditional | Jiangxi Yikang Medical Instrument Group Co., Ltd. |
| K130908 | 2013-10-03 | EZL | Traditional | Guangdong Baihe Medical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 100-249 |
|---|
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.