Stages, Microscope
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jiangsu and Shanghai: 2 hold an FDA registration.
- China (Shenyang) MED-Land IMP/EXP Corp., Ltd. Shanghai
- Diatrust Medical Co., Ltd. Jiangsu
What Is FDA Product Code KEJ?
Stages, Microscope is FDA product code KEJ, Class 1, 21 CFR 864.3600.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
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