The European Union has upgraded the requirements for the Class 1 Medical Device designation, and Hologenix, creators of Celliant, has met the stricter requirements for this market.
This means that compliant manufacturers can continue to use the CE mark on their EU products containing Celliant. Hologenix has been a pioneer in achieving regulatory status for its infrared technology and has a department dedicated to overseeing the regulations on a global scale, company officials said.
Celliant is either registered, designated or determined as a Class 1 Medical Device in 38 countries and cleared to market in 15, with more to follow, according to a news release.
Brand partners need to comply with the requirements that Hologenix provides, and do not have to pursue regulations on their own. Regulatory status validates the science and technology behind Celliant, a natural blend of bioceramic minerals that absorb body heat and reflect it back as therapeutic infrared energy, company officials said.
The list of products that are now registered in the EU as Class 1 Medical Devices has grown since 2014 when Hologenix first sought registration. The list now includes bed blankets, bed sheets, duvets, duvet covers, mattresses, mattress covers, pillows, heat-reflective upper and lower torso garments, therapeutic diabetic socks, compression socks/stockings, support bandages, wraps and limb mobilization/support skin adhesive tape.
The transition to the Medical Device Regulations in the EU for Celliant Class 1 medical devices includes more stringent requirements to demonstrate medical device safety for users, a refined quality management system and detailed technical documents.
“We see the Class 1 Medical Device designation and CE mark as a major benefit when marketing our products to the consumer — it is a win-win for brands and the end user,” said Julian Wolf, product manager with Blackroll, a European health and recovery supplier where Celliant is an ingredient in its blanket offering.
“Our unique international regulatory status and verified claim set are without doubt an extremely significant Celliant advantage — one that not only underscores the effectiveness of our technology, but also provides brand partners with the ability to differentiate their brand and products in an increasingly competitive market,” said Seth Casden, co-founder and CEO of Hologenix, headquartered in Pacific Palisades, California.
