Data / Medical devices / China / Shanghai Medconn Biotechnology Co., Ltd.
Shanghai Medconn Biotechnology Co., Ltd.: FDA-registered device maker in Jinshan District Shanghai, China, 2 510(k) clearances
Shanghai Medconn Biotechnology Co., Ltd. is registered with the FDA (registration 3043654757) in Jinshan District Shanghai, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3043654757
- Address
- No. 1018 Weichang Road, Shanyang Town, Jinshan District Shanghai, China, 201508
- Owner or operator
- Shanghai Medconn Biotechnology Co., Ltd. (10095004)
- Roles
- Manufacturer
- First device listed
- January 14, 2026
- Registered through
- 2026
- Brand names listed
- Medconn 8K HbA1c Assay Kit(HPLC), Medconn 8K HbA1c Column Kit(HPLC), Medconn HbA1c Assay Kit(HPLC), Medconn HbA1c Column Kit(HPLC), Medconn HbA1c Haemolyser, Medconn Hemoglobin A1c Calibrator, Medconn Hemoglobin A1c Control
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer | accessdata.fda.gov |
| Hemoglobin A1c Test System | PDJ | 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 6, 2026 | K252749 | Medconn 8K Glycated Hemoglobin Test System | PDJ | Substantially Equivalent | Shanghai Medconn Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 20, 2025 | K242911 | Medconn Glycated Hemoglobin Test system | PDJ | Substantially Equivalent | Shanghai Medconn Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 6, 2026. 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.