Nipro (Shanghai) Co., Ltd.
Registered establishment in Shanghai, China. 1 device type.
Nipro (Shanghai) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Needle, Hypodermic, Single Lumen. Its earliest product listing with the FDA dates from 2005.
Registration
| Registered name | NIPRO (SHANGHAI) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004138517 |
| FEI number | 3004138517 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 尼普洛（上海）有限公司 |
|---|---|
| Unified social credit code | 913100006072860411 |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 2555 BAOAN ROAD |
| Postal code | 201801 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | Class 2 | Nipro Hypodermic Needle | 2005 | 71 |
Clearances
No clearance names Nipro (Shanghai) Co., Ltd. as applicant. One is 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 |
|---|---|---|---|---|
| K052474 | 2005-11-10 | FMI | Traditional | Nipro Medical Corporation |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Employees | 1000 (planned capacity at Hefei facility) |
| Factory area | 207.8 acres (Hefei facility) |
| Main products | blood purification/dialysis equipment, single-use injection needles, blood dialysis devices, vacuum blood collection tubes, infusion therapy products |
| Certifications | ISO13485, CE, CFDA |
| Export markets | 56 countries |
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.