Outro produto da Lepu Medical recebe certificação sob MDR
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2022-10-12
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LEPU
2022.10.10，Ultraskin™ Hydrophilic Guide Wire developed by Lepu Medical has obtained the MDR certificate issued by the BSI Netherlands Notified Body (2797) and is approved for sale in the EU market. The certificate is valid for 5 years. Ultraskin™ Hydrophilic Guide Wire is the second product of Lepu Medical's high-risk class III product certified under MDR.
Let's Learn About Ultraskin™ Hydrophilic Guide Wire
Ultraskin™O fio guia hidrofílico é um fio guia intervencionista especial composto por fio de núcleo de nitinol, revestimento de plutônio com carboneto de tungstênio, revestimento hidrofílico e ponta afilada macia. Nitinol core wire oferece grande resistência à torção e retenção da forma da ponta, garantindo a transmissão 1:1 do eixo proximal para a ponta distal. O revestimento do plutônio com carboneto do tungstênio assegura a grande radiopacidade. Os fios de nitinol são cobertos com poliuretano e revestimento hidrofílico para excelente resistência à torção e entrega sem atrito nas posições desejadas. A ponta afilada macia de 30mm faz uma ponta macia do fio-guia para minimizar o dano à parede da embarcação. E existem dois tipos de ponta: reta e 135 ° angular.
The Ultraskin™ Hydrophilic Guide Wire is another MDR certified product following the Balâncio PTCA guide wire https://en.lepumedical.com/products/balancium-ptca-guide-wire/ , which accelerates the CE certification transition for the coronary intervention product line. The acquisition of this new certificate further proves the excellent performance of Lepu Medical's coronary intervention products and the strength of Lepu Medical, and accelerates the pace of the transition of Lepu Medical's coronary intervention access products to MDR, injecting new strength into the company's expansion into overseas markets. Lepu Medical will continue to speed up the transition of certificates for various products, quickly respond to the regulatory requirements for medical devices in overseas markets, and continue to contribute to the vigorous development of overseas markets.
