Sedana Medical’s products receive MDR certification
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has received Medical Device Regulation (MDR) certification, which secures EU market access for Sedaconda® ACD under the new MDR regulation, well ahead of the deadline in 2024.
"The new EU Medical Device Regulation (MDR) was implemented to ensure an even higher level of quality and safety for medical devices in Europe. This approval is the final and very important step for Sedana Medical in the transition into the new regulation. Therefore, while this outcome was expected, I am proud of Sedana Medical’s efforts to achieve this milestone to secure future market access for our products", says Johannes Doll, CEO of Sedana Medical.
An audit of the products’ technical and clinical documentation, affected by the new legal requirements, has been performed and approved by Sedana Medical's notified body.
For additional information, please contact:
Johannes Doll, CEO, +46 (0)76 303 66 66
Johan Spetz, CFO, +46 (0)730 36 37 89
Sedana Medical is listed on Nasdaq First North Growth Market in Stockholm.
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, firstname.lastname@example.org.
About Sedana Medical
Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient’s life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.
Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordic, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.
Sedana Medical was founded in 2005, is listed on Nasdaq First North Growth Market (SEDANA) and headquartered in Stockholm, Sweden.