Chengdu Daxan Innovative Medical Tech. Co., Ltd.
Manufacturer and brand owner in Chengdu, Sichuan, China. 1 device type, 2 products catalogued, 2 clearances.
Chengdu Daxan Innovative Medical Tech. Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Catheter, Straight. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
1device type
2products catalogued under its own name
2510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3023329815 |
| FEI number | 3023329815 |
| DUNS | 554453716 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 成都德信安创新医疗技术有限公司 |
|---|---|
| Unified social credit code | 91510115MA61WU232H |
| Source | NMPA UDI database |
Location
| City | Chengdu |
|---|---|
| Province | Sichuan |
| Address | East side of distribution Center 3,No.566,West Section of Kexing Road, Wenjiang District |
| Postal code | 611137 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Straight | Class 2 | Disposable Intermittent Catheter (TPU Catheter), PVC Hydrophilic Urethral Catheter | 2022 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Disposable intermittent catheter (TPU Catheter) | EZD | 140 |
| PVC Hydrophilic Urethral Catheter | EZD | 32 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243175 | 2025-06-26 | EZD | Traditional | This company |
| K212567 | 2022-12-07 | EZD | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Factory area | 10,000 square meters |
| Main products | Hydrophilic coated catheters, PVC catheters, Foley catheters, Ureteral stents |
| Certifications | FDA |
| Export markets | International markets |
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.