Sonoma Pharmaceuticals, Inc. announced on December 5, 2024, that it has successfully completed the transition of four of its products to the new European Union (EU) Medical Device Regulation (MDR) requirements. This achievement ensures continued market access in Europe.
The company was granted classification as a Class IIb medical device for several key products. These include Microdacyn60® Wound Care and Microdacyn60 Hydrogel, its scar gel product Epicyn®, and Pediacyn® for atopic dermatitis.
This successful transition is a critical regulatory milestone, allowing Sonoma to maintain and expand its commercial presence in the European market without interruption under the updated, more stringent regulations.
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