Data / Medical devices / China / Shanghai Yunze Biotechnology Co., Ltd.
Shanghai Yunze Biotechnology Co., Ltd.: FDA-registered device maker in Minhang Disctrict Shanghai, China, 1 510(k) clearance
Shanghai Yunze Biotechnology Co., Ltd. is registered with the FDA (registration 3026848661) in Minhang Disctrict Shanghai, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 27, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3026848661
- Address
- Room 301, 302-1, 401-1, Building 10, 760 Xinjun Ring Road, Minhang Disctrict Shanghai, China, 201112
- Owner or operator
- Shanghai Yunze Biotechnology Co., Ltd. (10087388)
- Roles
- Manufacturer
- First device listed
- February 21, 2023
- Registered through
- 2026
- Brand names listed
- PANABAY
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enzyme Immunoassay, Tracrolimus | MLM | 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 |
|---|---|---|---|---|---|---|
| January 27, 2023 | K203833 | Tacrolimus Assay Kit | MLM | Substantially Equivalent | Shanghai Genext Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 27, 2023. 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.