Shanghai Yunze Biotechnology Co., Ltd.
Registered establishment in Minhang Disctrict, Shanghai, China. 1 device type.
Shanghai Yunze Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Tracrolimus. Its earliest product listing with the FDA dates from 2023.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3026848661 |
| FEI number | 3026848661 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海云泽生物科技有限公司 |
|---|---|
| Unified social credit code | 913101157878696575 |
| Source | NMPA UDI database |
Location
| City | Minhang Disctrict |
|---|---|
| Province | Shanghai |
| Address | Room 301, 302-1, 401-1, Building 10, 760 Xinjun Ring Road |
| Postal code | 201112 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Enzyme Immunoassay, Tracrolimus | Class 2 | Panabay | 2023 | 1 |
Clearances
No clearance names Shanghai Yunze Biotechnology 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 |
|---|---|---|---|---|
| K203833 | 2023-01-27 | MLM | Traditional | Shanghai Genext Medical Technology Co., Ltd. |
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.