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Data / Medical devices / Gauge, Lens, Ophthalmic / China

FDA-registered makers of Gauge, Lens, Ophthalmic in China: 8 establishments

8 establishments in China are registered with the FDA to make Gauge, Lens, Ophthalmic (product code HLN). 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
Gauge, Lens, Ophthalmic
Product code
HLN
Country
China

Makers of Gauge, Lens, Ophthalmic in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Danyang Guanheng Optical, IncDan Yang Jiangsu, ChinaManufacturer0000api.fda.gov
Danyang Shiquan Optical Co.,ltd.Dan Yang Jiangsu, ChinaManufacturer0000api.fda.gov
Huaian Tisurg Medical Instruments Co., Ltd.Huaian City Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Taojing Co.ltdZHENJIANG Jiangsu, ChinaManufacturer0000api.fda.gov
Lianyungang Tiannuo Optical Instrument Co., Ltd.LIANYUNGANG Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Shanghai Lucidarx Optical LLCShanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Shenzhen Xinrun Optical Company LimitedShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Wenzhou Baibo Eyeglasses Co., LtdWenzhou Zhejiang, ChinaExporter 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.