ZOLL is One of the First Companies to Receive AED Approval Under the EU Medical Device Regulation (Mdr) Certificationgulation (MDR) certification

9 February 2024

ZOLL ® , an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that the ZOLL AED 3 ® defibrillator is approved by the Medical Devices Regulation 2017/745 of the European Union (EU), commonly known as EU MDR.

The EU MDR is the European Union Medical Devices Regulation 2017/745, published in 2017 by the European Parliament and the Council of the European Union. The objective of the EU MDR is to ensure a high level of safety and quality of medical devices produced in or supplied to the member countries of the European Union.

ZOLL has obtained CE marking for the ZOLL AED 3 defibrillator under the EU MDR.

“ZOLL is delighted to have received MDR certification for our ZOLL AED 3,” said Elijah White, president of ZOLL's resuscitation division. "This is the strictest level of European medical regulation for a medical device and represents ZOLL's ongoing commitment to product quality, safety and efficacy."

ZOLL continues to actively work to achieve EU MDR approval and certification for its entire product offering.

About ZOLL

ZOLL, an Asahi Kasei company, develops and markets healthcare products and software solutions that advance emergency care and save lives while increasing clinical and operational efficiency. With products for cardiac defibrillation and monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL offers a broad set of technologies that They help physicians, emergency services and firefighters, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary situations. For more information, visit www.zoll.com .

About Asahi Kasei

The Asahi Kasei Group contributes to improving the well-being of people around the world. Since its founding in 1922 with the ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown by proactively transforming its portfolio of activities to meet changing needs. With more than 48,000 employees worldwide, the company promotes a sustainable society by providing solutions to global challenges through its three sectors: materials, homes and healthcare. Its healthcare activities include devices and systems for intensive care, dialysis, therapeutic apheresis and manufacturing of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com .

Asahi Kasei is also dedicated to promoting sustainability initiatives and is helping to achieve a carbon-neutral society by 2050. For more information, 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 affiliates 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.

The statement in the original language is the official and authorized version of it. This translation is only a means of assistance and must be compared with the text in the original language, which is the only version of the text that will have legal validity.

Contacts

Media:
Matt Hogan
ZOLL
978-805-6561
media@zoll.com

Source: businesswire.com