Is Thinklabs One FDA approved?

Thinklabs has both CE and US FDA approval. 

Thinklabs has had FDA approval for a Class 2 diagnostic device since 2004. In 2017, Thinklabs received the CE (Conformite Europeen) mark, which indicates that Thinklabs products meet safety, health and environmental protection requirements in Europe. This enables Thinklabs to distribute its products throughout the European Union.

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