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Recently, Cardiolink Science, independently developed by Cardiolink Science(Shenzhen)Medical Technology Development Co., Ltd."Zhipeng" Single-Use Interventional Microcatheter、"Cardiolink Science" Peripheral Vascular MicroguidewireAnd"Ruishen" Balloon Dilation CatheterThree Interventional PathwaysCore Product, Successfully ObtainedEU Medical Device CE Certification。This is a product of Cardiolink Science since its establishment.The first-time acquisition of EU CE certification marks that its independent research and development capabilities and product quality system have gained international authoritative recognition., laying a solid foundation for a full-scale entry into the European and broader international markets.

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CECertification：Ticket to the European Market and Quality

Recognition at the Top of the Pyramid

The EU CE certification is the globally recognized "gold standard" for the safety and performance of medical devices, serving as the passport for products entering the EU and European Free Trade Association (EFTA) markets..CE certification requirements are extremely strict, representing globally“"High Standards, High Value, High Trust"Product threshold, passing this certification indicates that the product:

1. Safety and Effectiveness: Fully compliant with the highest requirements of the EU Medical Device Regulation (MDR);

2. International Passport: The EU is the world's second-largest medical device market, and obtaining CE certification means that Cardiolink Science's three core interventional access products are qualified for free circulation in more than 30 countries within the EU and its economic area.

3. Global Endorsement Effect: Greatly enhances professional user confidence, significantly improves global market recognition and procurement potential;

4. Breaking Policy Bidding Barriers: Providing strong support to meet the national policy requirements for encouraging domestically produced innovative devices to obtain higher international qualification certifications. 

This is undoubtedly an important milestone for a company that has always been committed to the innovation of medical devices produced in China.

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Three Arrows Unleashed: Tackling Clinical Pain Points with Technological Innovation

The three products that have obtained certification this time are solutions developed by Cardiolink Science based on the long-term accumulation of multiple core technologies from the B-E-S-T technology platform. They are specifically designed to address the support force for complex lesions in vascular interventions, the passability through medium-to-high resistance vessels, and the demand for precise treatment.

Zhipeng Single-Use Interventional Microcatheter: Continuing the "High Torque, High Flow" characteristics of the Cardiolink Science series microcatheters, the meticulously optimized multi-segment gradient combined with a three-layer catheter body structure ensures 1:1 torque control in tortuous vascular environments, providing strong assurance for rapid and safe access to target vessels.

Cardiolink Science's Peripheral Vascular Micro Guidewire: Precision nitinol core wire integrated with a coaxial support segment and a core-to-tip design at the distal end, offering top-tier maneuverability and kink resistance while ensuring excellent torque transmission and outstanding flexibility, providing clinicians with a highly successful crossing guidance tool.

Cardiolink Science Balloon Dilation Catheter: Tapered Gradual Tip and Composite Material Balloon Ensure Excellent Passability and Trackability, Superior Balloon Material and Craftsmanship Make the Balloon Both High-Pressure and Non-Compliant, Providing a Safe and Precise Dilation Solution for Peripheral AVF Stenosis Lesions.

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Cardiolink Science: China's Innovative Power Sets Sail Overseas

Cardiolink Science's headquarters is located in Pingshan, Shenzhen. The company has GMP-certified Class 10,000 production facilities in both Shenzhen and Beijing. As a national-level specialized and innovative "little giant" enterprise, the company focuses on advancing precise embolization therapy and continuously explores the field of tumor vascular intervention.Self2015Since its establishment in [Year], Cardiolink Science has obtained21Zhang San Class Medical Device Registration Certificate and15An overseas registration approvalThe company's product line covers three major fields: tumor vascular intervention, tumor minimally invasive energy intervention, and pan-vascular access intervention, demonstrating strong R&D capabilities and market expansion abilities. 

In recent years, the company has embarked on a new journey of product internationalization, accelerating the globalization of its products to benefit patients worldwide:

In March 2024, the microcatheter kit product successfully passed the Brazilian ANVISA registration approval and ISO13485 quality management system certification., marking the official entry of the company's products into the South American market;

In October 2024, the company's fully self-owned intellectual property "Bioresorbable Degradable Microspheres" was awarded the FDA Breakthrough Device Designation (BDD) in the United States.，Cardiolink Science's full-stack development innovation has gained recognition from international authoritative institutions and is expected to bring a revolutionary treatment solution to millions of knee osteoarthritis patients.；

In May 2025, the company's 3 vascular intervention products received marketing approval in Vietnam and Indonesia., marking a crucial step for China-produced vascular intervention solutions in the emerging Southeast Asian market, further accelerating the global accessibility process.

With the acquisition of this CE certification, Cardiolink Science's three core interventional access products will compete alongside world-renowned brands in the European market. This is not only a source of pride for Cardiolink Science but also reflects the enhancement of China's medical device innovation capabilities, setting an example for Chinese medical device companies to go global and participate in international competition.