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Data / Medical devices / Automated Urinalysis System / China

FDA-registered makers of Automated Urinalysis System in China: 17 establishments

17 establishments in China are registered with the FDA to make Automated Urinalysis System (product code KQO). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Automated Urinalysis System
Product code
KQO
Country
China

Makers of Automated Urinalysis System in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Chong Qing Teco Huayi Pharm. Co.Shapingba Dist., Chongqing, ChinaManufacturer1August 16, 2005000api.fda.gov
Acon Biotech (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
Ari Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Ave Science & Technology Co., LtdChangsha Hunan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changchun Merydi Bio-Tech Co., Ltd.changchun Jilin, ChinaManufacturer0000api.fda.gov
Changchun Wancheng Bio-Electron Co., Ltd.Changchun Jilin, ChinaManufacturer0000api.fda.gov
Contec Medical Systems Co., LtdQinhuangdao Hebei, ChinaManufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Honfield Precision Parts Co., LtdZhangmutou, Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Infitek Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Jilin Hongyi Bio-Tech Co., Ltd.Changchun Jilin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kunming Lianen Biotechnology Co., LTDKunming Yunnan, ChinaManufacturer0000api.fda.gov
Labpeak Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Scitek Global Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
URIT Medical Electronic Co., Ltd.Guilin Guangxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Weihai Kangzheng Medical Equipments Technology Co.,Ltdweihai Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated November 2, 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.