October 4, 2023 – Terumo announced that its ANGIO-SEAL™ VIP and FEMOSEAL™ vascular closure devices have secured CE certification under the European Union's new Medical Device Regulation (MDR), reaffirming their continued availability to physicians across Europe.
The ANGIO-SEAL VIP and FEMOSEAL devices are widely used vascular closure solutions that help achieve hemostasis following catheterization procedures, supporting faster patient recovery and ambulation.
"Achieving MDR certification for these devices underscores our ongoing commitment to meeting the highest regulatory standards while continuing to provide physicians with trusted vascular closure solutions," said a Terumo representative. "We are pleased that European physicians and patients can continue to rely on these established technologies."
The MDR represents a more rigorous regulatory framework for medical devices sold in the European Union, and this certification confirms that both devices meet its enhanced safety and performance requirements.
