Sonoma Pharmaceuticals Successfully Transitions First Products to New EU MDR Requirements for Class IIb Medical Devices [Yahoo! Finance]
Sonoma Pharmaceuticals, Inc. (SNOA)
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Source: Yahoo! Finance
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 asses
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News
- Sonoma Pharmaceuticals Successfully Transitions First Products to New EU MDR Requirements for Class IIb Medical DevicesAccesswire
- Sonoma Pharmaceuticals Announces Relaunch of Prescription Dermatology and Eye Care Product Lines in the United States [Yahoo! Finance]Yahoo! Finance
- Sonoma Pharmaceuticals Announces Relaunch of Prescription Dermatology and Eye Care Product Lines in the United StatesAccesswire
- Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance for Microcyn(R)-based Wound Care HydrogelAccesswire
- Sonoma Pharmaceuticals Second Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag [Yahoo! Finance]Yahoo! Finance
SNOA
Sec Filings
- 1/3/25 - Form 4
- 1/3/25 - Form 4
- 1/3/25 - Form 4
- SNOA's page on the SEC website