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The European Union (EU) has upgraded the requirements for the Class 1 Medical Device designation and Hologenix®, creators of CELLIANT®, has met the stricter requirements for this important market. This means that compliant manufacturers can continue to use the CE mark on their EU products containing CELLIANT. Hologenix has been a trailblazer in achieving regulatory status for its infrared technology and has an entire department dedicated to overseeing the regulations on a global scale. CELLIANT is registered, designated or determined as a Class 1 Medical Device in 38 countries and cleared to market in 15, with more to follow.
Brand partners simply 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. This is a benefit to the brands and a key differentiator for today’s consumers, providing a product they know is safe and that they can trust.
The list of products that are now registered in the EU as Class 1 Medical Devices has grown considerably since 2014 when Hologenix first sought registration and 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®, the leading European health and recovery supplier where CELLIANT is an important ingredient in their 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,” concluded Seth Casden, Hologenix Co-founder and CEO.