Ophthalmoscopes, Replacement Batteries, Hand-Held
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Beijing and Jiangsu.
- Beijing Hongdee Corporation Beijing
- Lianyungang Tiannuo Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code MSG?
Ophthalmoscopes, Replacement Batteries, Hand-Held is FDA product code MSG, Class 2, 21 CFR 886.1570.
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.
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