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ZOLL AED Plus Received Approval for AEDs Under the EU Medical Device Regulation (MDR) Certification
October 2 — CHELMSFORD, Mass. — ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the ZOLL AED Plus® defibrillator is approved under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR. The ZOLL AED 3® received MDR approval in January 2024.
EU MDR is the European Union Medical Device Regulation 2017/745 that was adopted 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 now has CE marking for the ZOLL AED Plus® defibrillator under the EU MDR.
“ZOLL is happy to have received our second MDR certification for our AED Plus,” said Elijah White, President of ZOLL’s Acute Care Technology division. “With this new certification, ZOLL customers will know that this device has passed the most stringent level of European medical regulation for a medical device.”
ZOLL continues to work diligently toward achieving EU MDR approval for the Powerheart G5® and certification for ZOLL’s full portfolio of products.
