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Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has successfully completed transition to the new European Union (EU) Medical Device Regulation (MDR) for four of its products in Europe.
Sonoma was granted classification as a Class IIb medical device for Microdacyn60® Wound Care and Microdacyn60 Hydrogel, its scar gel product Epicyn®, and Pediacyn® for atopic dermatitis.
The MDR was adopted in the EU in 2017 to replace the existing Medical Device Directive. The transition period for compliance was most recently extended to December 31, 2028 for non-implantable Class IIb and lower risk devices. In order to comply with the MDR, Sonoma's products needed to meet certain requirements relating to safety and performance and successfully undergo verification of regulatory compliance, or conformity assessment.
"Sonoma is pleased to have received the new Class IIb classification for our wound care, scar and atopic dermatitis products in the European Union, well ahead of the requisite compliance deadline," said Amy Trombly, CEO of Sonoma. "It is truly a testimony to the safety and efficacy of our products and strength of our clinical data. This is an important milestone made possible by the diligent preparation of our regulatory team to meet these new and more stringent standards for medical devices in Europe."
About Sonoma Pharmaceuticals, Inc.
Sonoma Pharmaceuticals is a global healthcare leader for developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound, eye, oral and nasal care, dermatological conditions, podiatry, animal health care and non-toxic disinfectants. Sonoma's products are clinically proven to reduce itch, pain, scarring, and irritation safely and without damaging healthy tissue. In-vitro and clinical studies of HOCl show it to safely manage skin abrasions, lacerations, minor irritations, cuts, and intact skin. Sonoma's products are sold either directly or via partners in 55 countries worldwide and the company actively seeks new distribution partners. The company's principal office is in Boulder, Colorado, with manufacturing operations in Guadalajara, Mexico. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.sonomapharma.com. For partnership opportunities, please contact busdev@sonomapharma.com.