Paragonix Secures EU MDR Approval for Five Organ Preservation Devices [Yahoo! Finance]
GETINGE AB UNSP/ADR (GNGBY)
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Source: Yahoo! Finance
WALTHAM, Mass., March 13, 2025 BUSINESS WIRE Paragonix Technologies , a pioneer in organ transplant technologies and organ procurement services, announced today that five of its devices have now received approval under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR. This approval further confirms Paragonix's compliance with the highest quality control standards for medical devices and allows continued access to the European market under the new EU regulations. The EU MDR sets quality standards for medical devices sold in the European Union, with an emphasis on safety, risk management and post-market surveillance. It replaces the former Medical Device Directive 93/42/EEC (MDD), introducing a more stringent framework and heightened requirements for market approval in Europe. With this approval, Paragonix solidifies its position as a global leader in organ preservation and transplant innovation. The approval includes five products develope
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