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Precision Medical Injection Molds & Custom Plastic Components

With over a decade of expertise in medical injection molding, we specialize in designing, manufacturing, and supplying high-precision injection molds and custom plastic components tailored to the healthcare industry. Our solutions adhere to strict global standards (ISO 13485, ISO9001) and are engineered to meet the unique demands of medical devices—from biocompatibility and sterility to dimensional accuracy and long-term reliability. Whether you need a single-cavity mold for a diagnostic tool or a high-volume production line for disposable medical parts, we deliver turnkey solutions that drive your product’s success in the global market.
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  • YIXUN mold

  • 8480419090

Introduction

With over a decade of expertise in medical injection molding, we specialize in designing, manufacturing, and supplying high-precision injection molds and custom plastic components tailored to the healthcare industry. Our solutions adhere to strict global standards (ISO 13485, ISO9001) and are engineered to meet the unique demands of medical devices—from biocompatibility and sterility to dimensional accuracy and long-term reliability. Whether you need a single-cavity mold for a diagnostic tool or a high-volume production line for disposable medical parts, we deliver turnkey solutions that drive your product’s success in the global market.

Our Core Capabilities

1. Medical-Grade Injection Molds

  • Design Excellence: Utilizing advanced CAD/CAM software (SolidWorks, AutoCAD) and finite element analysis (FEA), our engineering team optimizes mold designs for medical applications—reducing cycle times, minimizing material waste, and ensuring consistent part quality. We specialize in complex geometries, micro-molding, and multi-cavity molds (up to 64 cavities) for high-volume production.

  • Premium Mold Materials: Molds are crafted from medical-grade stainless steel (S136, H13) and hardened steel to withstand repeated sterilization cycles (autoclaving, ETO gas) and maintain dimensional stability. All mold surfaces are polished to Ra ≤ 0.02 μm for smooth, contamination-free part release.


2. Custom Medical Plastic Components

  • Biocompatible Materials: We process a wide range of medical-grade plastics, including:

    • Polypropylene (PP) – Disposable syringes, surgical trays

    • Polycarbonate (PC) – Diagnostic equipment, implantable devices

    • Polyethylene (PE) – Catheters, drug delivery systems

    • PEEK – High-temperature resistant surgical instruments

    • Silicone – Medical seals, prosthetics

      All materials are FDA-approved and meet USP Class VI biocompatibility standards.

  • Precision Molding: Our state-of-the-art injection molding machines (10–500 tons) feature servo-electric technology and closed-loop control systems, ensuring dimensional tolerance as tight as ±0.005 mm. We support micro-molding (parts as small as 0.1g) and overmolding (plastic-on-plastic, plastic-on-metal) for integrated medical devices.

  • Post-Processing Services: Complementary services include sterilization (ETO, gamma radiation), ultrasonic welding, laser marking, assembly, and packaging—all performed in a Class 8 cleanroom to maintain sterility and prevent contamination.

Manufacturing Process & Quality Assurance

Our medical injection molding process follows a strict, compliance-driven workflow to ensure product integrity:
  1. Design & Engineering: Collaborate with your team to refine product specifications, conduct DFM (Design for Manufacturing) analysis, and optimize mold design.

  2. Material Selection & Testing: Source certified medical-grade materials and perform pre-production material testing (tensile strength, biocompatibility, chemical resistance).

  3. Mold Fabrication: Precision machining, EDM, and polishing of mold components, followed by mold trial runs to validate part quality.

  4. Injection Molding: Automated production with real-time process monitoring (temperature, pressure, cycle time) to ensure consistency.

  5. Quality Inspection: 100% visual inspection, dimensional measurement (CMM, optical comparators), and functional testing (leakage, tensile strength) per customer requirements.

  6. Packaging & Delivery: Sterile packaging in ISO 8 cleanrooms, with full documentation (batch records, material certificates, test reports) for regulatory compliance.

Why Choose Us?

  • Medical Expertise: Dedicated focus on healthcare applications, with a team of engineers and technicians trained in medical device manufacturing and regulatory requirements.

  • Global Compliance: ISO 13485 certified, RoHS, and REACH standards—ensuring your products meet market access requirements worldwide.

  • Turnkey Solutions: From mold design to final assembly and sterilization, we handle every step of the production process, reducing lead times and simplifying your supply chain.

  • Cost-Effective Production: Optimized mold designs and automated manufacturing processes lower per-unit costs, even for high-volume orders.

  • Customer-Centric Support: 24/7 technical support, proactive communication, and flexible production schedules to meet your project timelines.

Applications

Our medical injection molds and plastic components are used in a wide range of healthcare products:
  • Disposable medical supplies (syringes, needles, surgical gloves, specimen containers)

  • Diagnostic equipment (test kits, sensor housings, labware)

  • Surgical instruments (handles, forceps, scissor blades)

  • Drug delivery systems (inhalers, insulin pens, IV catheters)

  • Implantable devices (orthopedic components, dental fixtures)

  • Medical device housings (MRI/CT scanner parts, ultrasound probes)

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Yixun is the China first generation mold maker, specialize in mold and moulding, provide one-stop plastic manufacturing service, feature in building medical and healthcare device tooling.
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  No.8, Lane 1, Xiju Road, Hengli Town, Dongguan City, Guangdong Province, China.
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  caobin@yixunmold.com
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