Global hemodialysis demand is surging (100M+ patients in China alone, plus growth in Europe, North America, Southeast Asia). For hemodialyzer manufacturers, reliable end cap plastic—certified to global standards—is non-negotiable. Zhongxin Huamei delivers FDA/CE-approved medical-grade plastic for hemodialyzer end caps, designed for safety, durability, and regional market compliance.
Why Hemodialyzer End Caps Need Certified Plastic
End caps are critical: they seal hollow fiber membranes, withstand vibration/pressure, and survive repeated sterilization (no leaks). Our plastic meets strict regional standards:
• FDA (U.S.), CE (EU), ISO 10993 (biocompatibility)
• TGA (Australia) for APAC market access
Product Specs: Hemodialyzer End Cap Plastic
Parameter | Detail | Compliance |
Biocompatibility | Passes cytotoxicity (ISO 10993-5), intradermal reaction (ISO 10993-6), sensitization (ISO 10993-10) | FDA, CE, ISO 10993 |
Sterilization | Resists EO, gamma radiation, autoclaving (121°C/30min) | EN ISO 11135, EN ISO 11137 |
Tensile Strength | ≥50 MPa | ASTM D638 |
Impact Strength | ≥20 kJ/m² (23°C) | ASTM D256 |
Color Customization | Full RGB, ΔE <0.8 (no variation) | Chi Mei color-matching system |
Heat Resistance | ≥120°C (0.45 MPa) | ASTM D648 |
4 Key Benefits for Global Manufacturers
1. Ready for Regional Markets: Pre-certified (FDA/CE/TGA) – skip extra testing for fast market entry.
2. Long-Lasting Sterility: Maintains seal/strength after 100+ sterilization cycles (fits disposable/reusable dialyzers).
3. Patient-Focused Colors: Custom hues soften blood flow visibility (ideal for Southeast Asia’s patient comfort priorities).
4. Reliable Supply: 10,000+ ton annual capacity, 48h samples, 7-day bulk lead times (supports EU/NA just-in-time production).
Partner for Regional Success
We tailor solutions to your target market:
Compliance Support: Provide FDA DMF, CE technical files for fast product registration.
Free Sample & Quote: Share your end cap specs (size, color, target market) – get a sample in 48h.
Zhongxin Huamei – Your Certified Partner for Medical-Grade Hemodialysis Plastics.
