Medical

Medical parts made of silicone

ISO 13485 Cleanroom Silicone Manufacturing

Our medical-grade silicone manufacturing facility features ISO Class 7 cleanroom environments, ensuring the highest standards of cleanliness and quality for biocompatible silicone products. We specialize in both HCR (High Consistency Rubber) and LSR (Liquid Silicone Rubber) medical applications.

Medical Silicone Expertise:

  • USP Class VI certified silicone for implantable devices

  • Biocompatible LSR molding for surgical instruments and medical devices

  • Pharmaceutical-grade silicone components for drug delivery systems

  • Medical device sealing solutions meeting FDA and ISO 10993 standards

With active collaborations with leading domestic medical companies and extensive experience in international medical device development, we provide comprehensive medical silicone supply chain solutions for global healthcare manufacturers.

Certifications & Capabilities:

  • ISO 13485 medical device manufacturing

  • Cleanroom silicone molding (ISO Class 7)

  • Sterilization-compatible materials (gamma, EtO, autoclave)

  • Regulatory compliance support for global markets