医疗器械制造商越来越多地淘汰传统材料，转而使用热塑性弹性体 （TPE） 来处理需要柔韧性或类似橡胶弹性的应用，他们转向 Teknor Apex 提供高质量、符合法规要求的 Medalist® TPE，并拥有良好的业绩记录。
医疗保健 TPS 奖牌得主®
毫不妥协的医疗保健质量：
采用 FDA 列出的食品级成分制成
生物相容性：符合 ISO 10993-5 标准
配方不含邻苯二甲酸盐、PVC、BPA、乳胶和动物源性材料
在多个 ISO-13485 认证的设施中生产，确保可靠、安全的供应
体验 Medalist® 的不同之处：
为广泛的医疗应用提供卓越的灵活性
严格的配方控制确保性能稳定
符合 REACH SVHC、65 号提案、CONEG 和 RoHS 等关键法规。
在要求允许的医疗保健和生物制药应用中，Medalist 医用级弹性体是有机硅、乳胶、TPU 和软质 PVC 的绝佳替代品，具有提供可持续性优势、成本优势、更大定制性和更高制造效率的潜力。
Applications of Medalist® Medical TPEs
技术资源
Medalist® 医用弹性体在多个 ISO-13485 认证的工厂中生产。如需我们的 ISO 认证副本，请访问我们的位置页面并选择佛蒙特州或新加坡。
Choose Teknor Apex for Medical Grade TPEs?
At Teknor Apex, we don’t just supply medical-grade thermoplastic elastomers — we provide confidence, compliance, and consistency. With decades of experience in healthcare materials and a reputation built on trust, we are a reliable partner to global medical device manufacturers and OEMs who demand proven performance and regulatory assurance.
Regulatory Expertise You Can Rely On
Our Medalist® Medical-Grade TPEs are developed under strict formulation and process controls to ensure compliance with key global standards, including FDA, ISO 10993, USP Class VI, REACH, and RoHS. Every compound is manufactured to support traceability and long-term supply integrity, helping customers meet demanding validation and regulatory requirements with confidence.
Proven Track Record in Healthcare Applications
For decades, Teknor Apex has been a trusted material partner for medical tubing, IV components, device housings, and other healthcare products. Our Medalist® compounds are engineered to deliver reliable performance, biocompatibility, and process efficiency in both disposable and reusable applications.
Global Supply & Consistent Quality
With manufacturing and technical support facilities across North America, Europe, and Asia, Teknor Apex ensures dependable supply and uniform quality worldwide. We maintain the same high standards and controlled processes across all regions to support your global programs seamlessly.
Tailored Formulations for Device-Specific Needs
No two medical devices are alike. Teknor Apex offers a range of formulations and hardness options to meet specific performance, bonding, and sterilization needs. Whether for overmolding, tubing, or flexible components, our team collaborates with customers to identify the right balance of functionality, feel, and compliance.
Consistency You Can Trust
Every Medalist® compound is built on controlled raw materials and repeatable processes to ensure batch-to-batch uniformity — a critical factor for medical manufacturers. Customers rely on Teknor Apex for materials that perform predictably, ensuring device reliability and long-term peace of mind.
