Instrumentation Difra
The videonystagmoscope transcribes the image of the patient's eye on a computer screen. The VIDEOSTAR can thus assess the reactions of the patient viewing his nystagmus during testing…
Lens, Fresnel, Flexible, Diagnostic
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Zhejiang.
- Wenzhou Eugenia Eyewear Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code HJJ?
Lens, Fresnel, Flexible, Diagnostic is FDA product code HJJ, Class 1, 21 CFR 886.1390.
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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