GRAND RAPIDS, MI – September 12, 2022
SunMed, a global leader in consumable medical devices for anesthesia and respiratory care, has received Medical Device Regulation (MDR) certification from the European Union (EU) on nine categories of its medical devices.
SunMed, a significant provider of medical products, celebrates its EU MDR certification for Salter Labs product families including Pressure Infusers (InfuseIT™), Humidifiers, Aerosol Masks, Nebulizers, Monitor Masks, Oxygen Masks, Oxygen Tubing, Oxygen Cannulas and Capnography Cannulas. The EU MDR certification means these products meet the essential requirements of the latest regulatory standards required for medical devices in Europe. Hank Struik, Chief Executive Officer, said, “SunMed is excited to meet this milestone EU MDR achievement enabling us to provide products to the EU which are critical to our customers and the patients they serve. This also provides the framework for SunMed to continue to grow our EU portfolio with additional product families.”
EU MDR is a replacement for the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMD). It provides rules to improve safety and quality for medical devices, as well as transparency for patients to protect public health and patient safety.
SunMed (www.sun-med.com), headquartered in Grand Rapids, Michigan and with manufacturing and distribution sites in the United States, Mexico, China, and Europe, is a leading medical device manufacturer, offering one of the most comprehensive portfolios of consumable anesthesia and respiratory care products. SunMed offers a product portfolio that spans the continuum of care from the first responder to home care, with safety, patient comfort, and clinical performance in mind. With over 1 million square feet of manufacturing space and 50+ engineers, SunMed has comprehensive expertise in all plastics materials and conversion—supported by a world-class Quality Management System. Our products are designed by clinicians for clinicians, with a focus on patient safety and comfort. Serving 97 countries worldwide, Salter Labs, Westmed, Ventlab, and Ethox are all a part of one brand family: SunMed.