Regulatory & Technical Information

The Dream Warmer™ is non-toxic and non-hazardous, as certified by an SGS Safety Data Sheet, and has passed TÜV Rheinland independent chemical testing.

After completing the US FDA application process, the FDA determined the Dream Warmer to be exempt as a medical device as it does not meet the definition of a medical device under applicable federal regulations.

The Dream Warmer is classified as a Class A medical device — the lowest risk category — and is officially registered with both the Rwanda Food and Drug Authority (RFDA) and the Central Drugs Standard Control Organisation (CDSCO) in India.