NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards. Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

Seller warrants good and clear title in goods subject to the sale (“Product”) and that the Product conforms at the time of shipment to a Certificate of Analysis or a Certificate of Compliance, or a Product Specification Sheet if any such document exists, and other specifications signed by Seller (“Specifications”).

Seller warrants good and clear title in goods subject to the sale (“Product”) and that the Product conforms at the time of shipment to a Certificate of Analysis, a Certificate of Compliance, or a Product Specification Sheet, if any such document exists, and other specifications signed by Seller (“Specifications”).

OUR CUSTOMER SUPPORT ACTIVITIES INCLUDE: • Food and Drug Administration (FDA) compliance support • Compliance with National Inventories • Biocompatibility compliance • REACH – European Legislation on Registration, Evaluation, Authorization and Restriction of Chemicals • Restriction on Hazardous Substances (RoHS) and Waste Electrical and Electronic Equipment (WEEE) electronics compliance • Data entry into the International Material Database System (IMDS) • Hazardous communication, including safety data sheets (SDS) and labeling GENERATING REGULATORY COMPLIANCE DOCUMENTATION INCLUDING: • California Proposition 65 • European Food Contact • Individual Customer Restricted Substance lists • Drug Master Files • Medical Application Files • Food and Drug Administration Certification • Potable Water Certification Contact us if you have questions or for specific information on your application’s regulatory compliance requirements.

Seller warrants good and clear title in goods subject to the sale (“Product”) and that the Product conforms at the time of shipment to a Certificate of Analysis, a Certificate of Compliance, or a Product Specification Sheet, if any such document exists, and other specifications signed by Seller (“Specifications”).

Seller warrants good and clear title in goods subject to the sale (“Product”) and that the Product conforms at the time of shipment to a Certificate of Analysis, a Certificate of Compliance, or a Product Specification Sheet, if any such document exists, and other specifications signed by Seller (“Specifications”).

Seller warrants good and clear title in goods subject to the sale (“Product”) and that the Product conforms at the time of shipment to a Certificate of Analysis, a Certificate of Compliance, or a Product Specification Sheet, if any such document exists, and other specifications signed by Seller (“Specifications”).