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Data / Medical devices / Urine Collection Kit (Excludes Hiv Testing) / China

FDA-registered makers of Urine Collection Kit (Excludes Hiv Testing) in China: 6 establishments

6 establishments in China are registered with the FDA to make Urine Collection Kit (Excludes Hiv Testing) (product code OIE). 0 have 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
Urine Collection Kit (Excludes Hiv Testing)
Product code
OIE
Country
China

Makers of Urine Collection Kit (Excludes Hiv Testing) in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Equinox Biotech Co., Ltd.Shantou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Primecare Medical Co.,Ltd.hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Phase Scientific (Shenzhen) Company LimitedShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Primecare Medical (Suzhou) Co.,Ltd.Changshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Zhejiang Gongdong Medical Technology Co., LtdTAIZHOU Zhejiang, ChinaContract manufacturer, 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.