Moptim
The DEA is intended to do the exams related to the analysis and possible diagnosis of Dry Eye Disease(DED) through the connection of the device to you pc, and particularly. •…
Keratoscope, Battery-Powered
Who Makes This Device Type in China?
3 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Guangdong.
- Lianyungang Tiannuo Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
- Shenzhen Certainn Technology Co., Ltd. Guangdong
- Taizhou City K&W International Trade Co., Ltd. Jiangsu
How Is HLR Classified?
Keratoscope, Battery-Powered is FDA product code HLR, Class 1, 21 CFR 886.1350.
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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