Jiangxi Sanxin Medtec Co., Ltd.
Registered establishment in Nanchang, Jiangxi, China. 6 device types, 3 clearances.
Jiangxi Sanxin Medtec Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Syringe, Piston and 4 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | JIANGXI SANXIN MEDTEC CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005246939 |
| FEI number | 3005246939 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江西三鑫医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91360100613026983X |
| Source | NMPA UDI database |
Location
| City | Nanchang |
|---|---|
| Province | Jiangxi |
| Address | No.999 Fushan Road, Xiaolan Economic |
| Postal code | 330200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | I.V. Catheter | 2015 | 12 |
| Mask, Surgical | Class 2 | Disposable Medical Face Masks | 2021 | 125 |
| Needle, Hypodermic, Single Lumen | Class 2 | YI XIN Sterile Syringe, Yixin Sterile Syringe FOR Single USE, FOR Single USE | 2008 | 71 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Class 2 | SANSIN Tubing Sets for Hemodialysi | 2021 | 5 |
| Syringe, Antistick | Class 2 | YI XIN Safety Syringe, Yixin Safety Syringe | 2008 | 39 |
| Syringe, Piston | Class 2 | YI XIN Sterile Syringe, Yixin Sterile Syringe FOR Single USE, FOR Single USE | 2008 | 60 |
Clearances
3 clearances name Jiangxi Sanxin Medtec Co., Ltd. as applicant. 2 are held by another company 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 |
|---|---|---|---|---|
| K202796 | 2021-09-06 | FJK | Traditional | This company |
| K202719 | 2021-01-04 | FXX | Traditional | This company |
| K142797 | 2015-06-18 | FOZ | Traditional | This company |
| K050999 | 2005-09-02 | FMF | Traditional | Jiangxi Sanxin (Eversincere) Medical Devices Group |
| K042102 | 2005-03-08 | MEG | Traditional | Jiangxi Sanxin (Eversincere) Medical Devices Group |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1997 |
|---|---|
| Employees | 2157 |
| Main products | Blood purification, Drug delivery systems, Vascular intervention, Critical care medicine, Biomedical materials |
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.