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Shanghai Medconn Medical Technology Co., Ltd.: FDA-registered device maker in Shanghai, China, 2 510(k) clearances

Shanghai Medconn Medical Technology Co., Ltd. is registered with the FDA (registration 3043149833) in 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 2, 2026.

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FDA registration number
3043149833
Address
No. 1018 Weichang Road, Shanyang Town,Jinshan District, Shanghai, China, 201508
Owner or operator
Shanghai Medconn Medical Technology Co., Ltd. (10094820)
Roles
Manufacturer
First device listed
December 26, 2025
Registered through
2026
Brand names listed
MQ-3000/ MQ-3000PT Glycated Hemoglobin Analyzer, Medconn 8K Glycated Hemoglobin Test System, Medconn 8K Glycated Hemoglobin Analyzer, Medconn Glycated Hemoglobin Test system(MQ-3000/MQ-3000PT)

Devices it lists

DeviceProduct codeClassRoleSource
Assay, Glycosylated HemoglobinLCP2Manufactureraccessdata.fda.gov
Hemoglobin A1c Test SystemPDJ2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 6, 2026K252749Medconn 8K Glycated Hemoglobin Test SystemPDJSubstantially EquivalentShanghai Medconn Medical Technology Co., Ltd.accessdata.fda.gov
June 20, 2025K242911Medconn Glycated Hemoglobin Test systemPDJSubstantially EquivalentShanghai 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.