Data / Medical devices / China / Chengdu Daxan Innovative Medical Tech. Co., Ltd.
Chengdu Daxan Innovative Medical Tech. Co., Ltd.: FDA-registered device maker in chengdu Sichuan, China, 2 510(k) clearances
Chengdu Daxan Innovative Medical Tech. Co., Ltd. is registered with the FDA (registration 3023329815) in chengdu Sichuan, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2025. Registered through 2026. 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.
- FDA registration number
- 3023329815
- Address
- East side of distribution Center 3,No.566,West Section of Kexing Road, Wenjiang District, chengdu Sichuan, China, 611137
- Owner or operator
- Chengdu Daxan Innovative Medical Tech. Co., Ltd. (10086949)
- Roles
- Manufacturer
- First device listed
- December 26, 2022
- Registered through
- 2026
- Brand names listed
- Disposable Intermittent Catheter (TPU Catheter), PVC Hydrophilic Urethral Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Straight | EZD | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 26, 2025 | K243175 | Disposable Intermittent Catheter (TPU Catheter) | EZD | Substantially Equivalent | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | accessdata.fda.gov |
| December 7, 2022 | K212567 | PVC Hydrophilic Urethral Catheter | EZD | Substantially Equivalent | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 26, 2025. 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.