ZOLL One of the First to Receive Approval for AEDs Under the EU Medical Device Regulation (MDR) Certification

2024-02-08
Business Wire
上市批准
CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the ZOLL AED 3® defibrillator is approved under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR.
EU MDR is the European Union Medical Device Regulation 2017/745 that was released in 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.
ZOLL has now obtained CE marking for the ZOLL AED 3 defibrillator under the EU MDR.
“ZOLL is very pleased to have received MDR certification for our ZOLL AED 3,” said Elijah White, President of ZOLL’s Resuscitation division. “This is the most stringent level of European medical regulation for a medical device and represents ZOLL’s long-standing commitment to product quality, safety, and efficacy.”
ZOLL continues to work diligently toward achieving EU MDR approval and certification for ZOLL’s full portfolio of products.
About ZOLL
ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 48,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.
Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/.
Copyright © 2024 ZOLL Medical Corporation. All rights reserved. ZOLL AED 3 and ZOLL AED Plus are trademarks or registered trademarks of ZOLL Medical Corporation and/or its subsidiaries in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.
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