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Fogg System Company, Inc. Achieves EU MDR Compliance for CE Marking of its Class 1 Medical Device Cable Products
Aurora, Colorado, 26 March, 2025 – Fogg System Company, Inc., a leading supplier of medical cable products, such as Invasive Blood Pressure (IBP) Interface cables, IBP Adapter cables, and various analog cables used to transmit patient data, is proud to announce that it has successfully met the requirements of the European Union Medical Device Regulation (EU MDR) for CE marking.
This achievement reaffirms the company’s commitment to quality, safety, and regulatory excellence in delivering high-quality medical devices to the European market.
With ISO 9001:2015 and ISO 13485:2016 quality certifications, along with FDA 510(k) clearance, compliance with the EU MDR (Regulation (EU) 2017/745) ensures that Fogg System Company, Inc.’s products meet the highest standards for patient safety, performance, and clinical efficacy. The CE marking allows the company to continue providing innovative medical solutions across the European Economic Area (EEA).
Our partners, including Transducer and Monitor OEMs, both domestically and internationally, will be able to take advantage of our ability to provide solutions for their complex cable requirements, while maintaining compliance with evolving regulatory demands.
“We are thrilled to achieve EU MDR certification, demonstrating our dedication to regulatory compliance and patient safety,” said David Blair, President at Fogg System Company, Inc. “This milestone reflects the hard work of our team and our ongoing commitment to delivering best-in-class medical devices to healthcare professionals worldwide.”
About Fogg System Company, Inc.
Fogg System Company is a leading manufacturer and supplier of Invasive Blood Pressure (IBP) Interface and Adapter cables, as well as Patient Simulators. With over 50 years in business, Fogg System Company has built a reputation for excellence in the medical device industry. Fogg’s Quality Policy is to provide excellent products for its customers and to help its customers be confident that the products and services Fogg provides to them will meet their requirements.
For more information about Fogg System Company, Inc and its certified products, please visit https://www.foggsystem.com/ and follow us on LinkedIn at Fogg System Company.
For additional information, contact:
Chris Richards – Sales Manager
crichards@foggsystem.com
sales@foggsystem.com
+1 303.344.1883
Fogg System Company, Inc.
15592 East Batavia Drive
Aurora, CO 80011
USA