Key Approvals:
✅ ISO 13485 – Medical device quality management system certified
✅ ISO 10993 – Biocompatibility tested for patient contact applications
✅ USP Class VI – Meets pharmaceutical-grade material standards
✅ FDA 21 CFR 177.2600 – Compliant for repeated sterilization (ETO/autoclave)
✅ CE Medical Directive (93/42/EEC) – EU market approval

Why It Matters:
• Accelerates FDA/CE submission for your medical devices
• Guarantees performance in sterilization cycles
• Reduces biological contamination risks