Illuminator, Non-Remote
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration. 1 is a contract manufacturer.
- Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Guangdong, contract manufacturer
- Modern Medical Equipment Manufacturing Ltd. Guangdong, contract manufacturer
What Is FDA Product Code FTF?
Illuminator, Non-Remote is FDA product code FTF, Class 2, 21 CFR 878.4580.
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.