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Data / Medical devices / Cup, Eye

Cup, Eye (LXQ): 5 FDA-registered makers in 2 countries

5 establishments in 2 countries are registered with the FDA to make Cup, Eye (product code LXQ, Class U). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on September 1, 2015, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LXQ
Device class
U
Medical specialty
Unknown

Makers by country

CountryMakers
China3
United States2

Makers of Cup, Eye

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Apothecary Products, LLC.Burnsville, MN, United StatesRepackager or relabeler, Specification developer1July 9, 2014000api.fda.gov
Dynarex Corp.Middletown, NY, United StatesSpecification developer1September 1, 2015000api.fda.gov
Ningbo HSCC Medical Technology Co., LtdNingbo Zhejiang, ChinaManufacturer1September 1, 2015000api.fda.gov
Shun Sze Industrial (shenzhen) Co., LtdSHENZHEN Guangdong, ChinaContract manufacturer0000api.fda.gov
Suzhou Pulikang Medical Device Co LtdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated September 1, 2015. 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.