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Data / Medical devices / Thermocycler, Generic / China

FDA-registered makers of Thermocycler, Generic in China: 5 establishments

5 establishments in China are registered with the FDA to make Thermocycler, Generic (product code OUL). 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
Thermocycler, Generic
Product code
OUL
Country
China

Makers of Thermocycler, Generic in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CITOTEST Labware Manufacturing CO., LTD.Haimen Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Citotest Scientific Co.,ltd.Nanjing Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.GUANGZHOU Guangdong, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Hangzhou Bioer Technology Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Infitek Co., Ltd.Shanghai, ChinaManufacturer0000api.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.