Dornier MedTech (Dornier) became the world’s first integrated urology company to become certified under the European Union’s new medical device regulation (MDR). Clinicians are guaranteed the highest quality devices as they manage the growing prevalence of kidney stone disease in the region.
The MDR certification will replace the former EU Medical Device Directive (MDD) on 26th May 2021. It includes a more robust legislative framework that enforces a higher standard of public health and patient safety. Despite the challenges imposed by COVID-19, Dornier achieved the EU MDR certification, one of the highest global standards. This is testament that Dornier has the expertise to fulfil its commitment to urology and meet the growing needs of the field.
Dornier achieved the MDR certification for its Class IIb products: Dornier Delta® III, one of the most powerful lithotripters in the market that utilizes Dornier’s Extracorporeal Shock Wave Lithotripsy (ESWL) technology; and the Dornier UIMS™, a state-of-the-art information management software providing enhanced imaging and efficiency to support clinicians in treating kidney stones.
Yau Chung Wong, Chief Operating Officer at Dornier MedTech, said,
“This certification is an important milestone for us. It is a testament to the high quality of Dornier’s ESWL medical devices that is now the gold standard for non-invasive kidney stone treatment, which will significantly bolster clinicians’ ability to continue delivering the highest standard of care to patients.”
Dornier is the pioneer of ESWL, the first non-invasive treatment for kidney stones, and is dedicated to extending its urology footprint through the expansion of its portfolio which now includes urological lasers, ESWT solutions and urology consumables. True to its spirit of innovation, Dornier consistently delivers modern urological solutions, powered by the latest technologies. The Dornier 5G (5th generation) line of devices features innovations that enable urologists to best serve their patients.
Dornier is headquartered in Munich, Germany and is a subsidiary of Advanced MedTech, a medical device technology leader based in Singapore.
Thomas Harding / Khushboo Tanna / Maryanne Lee
About Dornier MedTech
Dornier MedTech is a medical device company headquartered in Munich, Germany, and is a full subsidiary of Advanced MedTech.
As pioneers of the shockwave lithotripsy method and a leader in urological care, Dornier is one of the most trusted names in the industry. Through its deep-rooted spirit of entrepreneurship and excellence, Dornier continues to spearhead innovation in urology, developing some of the highest quality urological devices on the market today.
Given its vast array of clients, Dornier’s aim is to lead technology and improve life across the globe.
For more information, visit www.dornier.com.
About Advanced MedTech
Advanced MedTech Holdings is a global medical technology leader with a core focus in urology devices and services. Headquartered in Singapore, with operations in US, Germany, Spain, France, Italy, China, Malaysia and Japan, the Company serves millions of patients and physicians in 100 countries worldwide. Advanced MedTech Holdings makes strategic investments in disruptive medical technology companies, strengthening its portfolio of healthcare solutions for customers around the world. Advanced MedTech Holdings is a wholly-owned subsidiary of Temasek. For more information on Advanced MedTech Holdings, please visit www.advanced-medtech.com.
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