Detector, Ultraviolet
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong.
- Foshan Coxo Medical Instrument Co., Ltd. Guangdong
How Is EAQ Classified?
Detector, Ultraviolet is FDA product code EAQ, Class 2, 21 CFR 872.6350.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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