LUMENDI RECEIVES CE MARK FOR DILUMEN™ EZ¹ AND DILUMEN™ C¹, EXPANDING FOOTPRINT IN THE EUROPEAN MARKET

ZUG, Switzerland, Oct. 29, 2025 /PRNewswire/ 

Lumendi AG, a leader in advanced endoluminal technologies, today announced that its U.S. subsidiary, Lumendi LLC, has received CE certification for its DiLumen™ EZ¹ and DiLumen™ C¹ devices, enabling commercial distribution across the European Union (EU) and other global markets. Both products are single-use, disposable endotherapy devices designed for complex colon procedures.

Already available in the U.S. for two years, the EZ¹ and C¹ build on the success of the DiLumen EZ-Glide platform, which previously received CE certification, with more streamlined and cost-effective designs. The CE Mark confirms compliance with EU medical device regulations.

“This certification is a key milestone in our global strategy to expand access to minimally invasive endoluminal procedures,” stated Peter Johann, Ph.D., Executive Chairman of Lumendi AG. “We will continue strengthening our market presence through our partnership with MICRO-TECH Endoscopy, which currently distributes our products in the U.K. and Ireland and our other international representation through independent distributors in Europe who are awaiting our new devices.”

CE certification of medical devices is required to allow free marketability within the European Economic Area. Lumendi previously received and maintained CE certification to the EU Medical Device Directive for DiLumen EZ Glide since July 2018. This new certification, under EU 2017/745 Medical Device Regulation, expands the certification scope to the complete DiLumen product family. Lumendi has also maintained certification of its Quality Management System under ISO 13485:2016 since July 2017.

To date, over 6,000 procedures have been performed globally using the DiLumen Endoscopic Interventional Platform. Numerous published clinical studies, abstracts, and case reports have demonstrated its benefits, safety and cost-effectiveness.

The DiLumen™ EZ¹ and DiLumen™ C¹ are non-sterile, single-use sleeves that fit over a standard endoscope, stabilizing it in the large intestine and enhancing access, visualization, diagnosis and precision treatment.

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