The NextVein V800NV Project Vein Finder, as is true for most non-contact projection vein visualization systems, is a Class 1 510(k) exempt device in the US and a Class 1 device the EU. As such it does not require FDA approval such as a 510K or PMA.
Detailed regulatory certifications can be found in the user manual at support.nextvein.com.
The V800NV is manufactured for NextVein LLC by Shenzhen Vivolight Medical Device & Technology Co., Ltd.
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