Cup, Eye
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Zhejiang: 3 hold an FDA registration. 1 is a contract manufacturer.
- Ningbo Hscc Medical Technology Co., Ltd. Zhejiang
- Shun SZE Industrial (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
- Suzhou Pulikang Medical Device Co Ltd Jiangsu
How Is LXQ Classified?
Cup, Eye is FDA product code LXQ, unclassified.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
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