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🏥 HEALTHCARE · INNOVATIVE MATERIALS

TECHNYL® Healthcare Solutions

Safe · Reliable · Durable · Traceable | High-Performance Polyamides for Sustainable Medical Solutions
INDUSTRY REQUIREMENTS

Safe, Reliable Polyamide Solutions for Healthcare

The healthcare industry demands the most stringent material requirements: regulatory compliance, traceability, biocompatibility, and sterilization compatibility — all essential. DOMO Chemicals’ TECHNYL® high-performance polyamides are designed to meet these needs, providing safe, reliable, and durable material options for medical device manufacturers.

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“Safe · Reliable · Durable”

TECHNYL® polyamides are engineered to meet the needs of the healthcare industry, providing safe, reliable, and durable high-performance materials.

KEY REQUIREMENTS

Four Core Requirements for Healthcare Materials

DOMO strictly adheres to standards and regulations required by medical device manufacturers

📜 Regulatory Compliance

Plastic materials used in medical devices must adhere to applicable regulatory standards, including FDA, EMA, and other global health authorities. DOMO diligently monitors its material certifications and keeps customers informed of compliance changes.

✓ FDA · EMA · Global Regulatory Compliance
🔍 Full Traceability

Comprehensive tracking and documentation of all raw materials involved in production, combined with rigorous quality control, ensures traceability and material uniformity from source to finished product.

✓ Full Tracking ✓ Quality Control ✓ Material Uniformity
🧬 Biocompatibility

Biocompatibility testing evaluates medical device compatibility with biological systems. TECHNYL® grades meet ISO 10993 and USP Class VI (USP 87/88) standards, ensuring safety when in contact with patients.

✓ ISO 10993 ✓ USP Class VI (87/88)
🧪 Sterilization Compatibility

Medical devices are typically sterilized to prevent infection risks. DOMO provides sterilization compatibility test results upon request, covering multiple sterilization methods (EO, Gamma, E-beam, Steam, etc.).

✓ EO · Gamma · E-beam · Steam
PRODUCT PORTFOLIO

Healthcare Product Series

Diverse solutions for different medical applications

🔹 Standard Materials

Versatile and reliable base solutions suitable for various medical applications.

🔹 High-Flow / High-Glass-Filled

Address warpage and dimensional stability issues for precision medical device components.

🔹 Sustainable · TECHNYL 4EARTH

Eco-friendly alternatives with certified low CO₂ carbon footprint, supporting healthcare sustainability goals.

🔹 Food/Water Contact · TECHNYL SAFE

Approved food and drinking water contact solutions for medical and related applications.

💡 DOMO is continuously developing healthcare grades that meet key requirements including regulatory compliance, traceability, biocompatibility, and sterilization for the most demanding applications.

CHANGE MANAGEMENT

Change Management — Transparent Communication, Prior Notification

Customers will receive prior notification of any changes to the performance, processing, or formulation of the final product, enabling medical device manufacturers to assess impacts and take appropriate actions.

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Prior Notification
Performance·Processing·Formulation
QUALITY ASSURANCE

GMP Manufacturing — Consistent Quality Control

DOMO ensures its grades are consistently produced and controlled according to quality standards and GMP requirements. Every step from raw materials to finished products undergoes rigorous quality inspection.

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GMP Certified
Consistent Quality Control
CUSTOMER SUPPORT

Comprehensive Customer Support

DOMO’s experienced team of application development specialists offers comprehensive design and laboratory support to bring your ideas to life, from initial conceptualization to full-scale production.

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Full Support
From Concept to Production

⚠️ Important Notice It is solely the responsibility of the medical device manufacturer to determine that the use of DOMO’s grade is safe, lawful, and technically appropriate for the intended use. DOMO MAKES NO WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE SUITABILITY OF ITS PRODUCTS FOR MEDICAL USE.

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TECHNYL® Healthcare Solutions
Safe · Reliable · Durable · Traceable
✓ FDA/EMA Compliance ✓ Full Traceability ✓ ISO 10993 / USP Class VI ✓ Sterilization Compatible
Learn More →
📋 TECHNYL®, TECHNYL 4EARTH®, TECHNYL SAFE® are registered trademarks of DOMO Chemicals. This information is based on DOMO Chemicals official website. Medical device manufacturers are solely responsible for validating material suitability for their specific applications.
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