Regulatory Information

The NextVein V800NV Project Vein Finder, as is true for most non-contact projection vein visualisation systems, is a Class 1 510(k) exempt device in the US and a Class 1 device the EU & Australia. As such it does not require FDA approval such as a 510K or PMA.

The NextVein V800NV Project Vein Finder is TGA Approved (395977). See ARTG Certificate here.

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.