BrosMed Medical Announces CE MDR Approval of Introducer Sheath Set
Release time:
2026-03-05
Advanced vascular access solution meets EU's stringent new regulatory standards, enabling commercial launch across European markets
March 4, 2026 – BrosMed Medical, a dedicated manufacturer of vascular interventional devices, is proud to announce that its Introducer Sheath Set has successfully obtained certification under the European Union’s Medical Device Regulation (MDR 2017/745), receiving the CE mark.
This milestone underscores the company’s commitment to the highest standards of quality, safety, and clinical performance, and further strengthens its presence in the European market.
Thinner. Stronger. Smoother.
Designed to meet the evolving demands of modern vascular interventions, the newly certified Introducer Sheath Set delivers an optimal balance of profile, strength, and deliverability:
- Thinner Wall Design
Optimized wall thickness allows for a larger inner lumen under the same French size, supporting device compatibility while minimizing vascular trauma. - Stronger Construction
Excellent kink resistance combined with enhanced flexibility ensures reliable performance in tortuous anatomy without compromising structural integrity. - Smoother Access Experience
A smooth, tapered tip design facilitates atraumatic vessel entry and seamless transition during insertion. - Advanced Hydrophilic Coating Option
Available with a high-performance hydrophilic coating to provide enhanced lubricity, improved pushability, and easier insertion and removal. - Secure and User-Friendly Components
A well-designed cross-cut hemostasis valve helps maintain effective blood control, while the “snap-on” dilator lock mechanism ensures stable and intuitive assembly. - Comprehensive Configurations
Offering a comprehensive size matrix from 4F to 12F and lengths spanning 4–25 cm, the system ensures broad clinical applicability, complemented by customizable kit configurations to meet diverse procedural requirements.
For more information about our Introducer Sheath Set and other medical device solutions, please visit BrosMed website or contact us via e-mail: Sales@brosmed.com.
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