Regulatory Filings • Oct 18, 2024
Regulatory Filings
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Medistim receives EU MDR certificates for MiraQ systems and TTFM probes
(Oslo, October 18, 2024) - Medistim ASA (OSE: MEDI) is a niche market leader in
ultrasound technology, headquartered in Oslo, Norway. The company specializes in developing and commercializing advanced medical equipment for Cardiac, Vascular, and Transplant surgeries. Today, the company announced it has received EU Medical Device Regulation (MDR) certification for its MiraQ™ ultrasound systems and Transit Time Flow Measurement (TTFM) probes.
After years of preparation, Medistim has successfully obtained its first CE certificates under the latest EU Medical Device Regulation (EU MDR 2017/745).
This achievement represents a key milestone, affirming Medistim’s compliance with the most rigorous medical device standards set by the European Union. The new EU MDR imposes stricter requirements on safety, performance, and traceability of medical devices, with the goal of enhancing patient protection. Medistim’s successful certification underscores its dedication to excellence and its mission to deliver high-impact solutions that make a clinically significant difference in healthcare worldwide.
“Receiving the CE certificate under the EU MDR for our MiraQ™ system platform is a testament to the dedication and hard work of our entire team," said Kari E. Krogstad, President and CEO at Medistim. "This accomplishment reflects our unwavering commitment to delivering safe and reliable medical devices to our customers worldwide."
About Medistim:
Medistim was established in 1984 and has a track record of profitable growth
over the past 20 years. The company is a pioneer within its segment and
continues to invest in new product development. Medistim has wholly owned
subsidiaries with sales organizations in the USA, Canada, China, Germany, UK, Spain, Denmark, Sweden and Norway, in addition to around 60 distributors in Europe, Asia, the Middle East, Africa, and South America.
For more information, visit the Medistim home page: www.medistim.com
For more information, contact:
President and CEO, Kari E. Krogstad, Medistim ASA
Tel: + 47 918 38 110
Email: [email protected]
CFO, Thomas Jakobsen, Medistim ASA
Tel: + 47 906 59 940
Email: [email protected]
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