On September 2, 2020, Zeus Industrial Products, Inc. (hereinafter referred to as "Zeus"), the world’s leading polymer solutions provider and material science innovation company, today announced the official launch of the company’s first product in compliance with the European Union Polyimide (PI) pipes under the Chemical Registration, Evaluation, Authorization and Restriction Regulation (REACH) and the European Union’s Medical Device Regulation (EU MDR). Previously, the company had verified the compliance of its PI and PI Glide (a smoother composite material composed of polyimide and polytetrafluoroethylene) through an independent laboratory.
REACH, the abbreviation of Registration, Evaluation, Authorization and Restriction of Chemicals, is a regulation formulated by the European Union to restrict the entry of hazardous materials into its market. This effective control of chemicals can protect human health and environmental safety. The regulation requires all companies that produce and sell chemical substances in the European Union to manage related product risks.
The full name of EU MDR is European Medical Device Regulation, which can ensure that medical devices produced in Europe or entering Europe meet high quality and safety standards. REACH focuses on material composition, while EU MDR regulations specifically target medical devices and cover a wider range.
Polyimide is a high-performance polymer with excellent chemical, thermal and mechanical properties. This material is suitable for a variety of medical applications and is ideal for constructing vascular and non-vascular catheters. Zeus offers a variety of polyimide pipes, and the size, thickness, color and smoothness can be customized according to customer requirements.
Bob Chaney, senior vice president of global sales and marketing at Zeus Industrial Products, Inc., said: "We know that strict regulatory requirements have placed a great burden on customers, so we will do our best to help them solve these problems. Difficulty. If the PI that meets the regulatory standards is not available, companies may have to consider other materials or shelve plans to sell products in Europe. Our polyimide products comply with various regulations, which not only reassure customers, but also avoid Material re-evaluation, product redesign or postponement of product launch can save hundreds of thousands of dollars in cost."
Zeus Industrial Products, Inc. Senior Product Manager Matt Allen (Matt Allen) said: "Through continuous improvement of the manufacturing process, Zeus has finally brought to the global market a polyimide pipe that meets REACH and EU MDR requirements. So far , We are the only supplier in the world that can do this. While complying with regulations, no modification is required to the finished product. After a comprehensive laboratory test, Zeus has confirmed the chemical structure and mechanical structure of its polyimide pipes. Performance is not affected."
Important information at a glance
• Zeus is the only supplier that can provide polyimide pipes that meet REACH and EU MDR requirements, and the products have officially landed on the global market. • The REACH regulation aims to restrict the entry of hazardous materials into EU countries.
•EU MDR ensures that medical devices manufactured in or entering Europe meet high quality and safety standards.
•Polyimide is suitable for various medical applications, especially catheter manufacturing.
• Zeus's PI and PI Glide products comply with relevant regulations, so customers do not need to re-evaluate materials, redesign products or postpone product launches.
•Zeus provides polyimide pipes of various sizes, thicknesses, colors and smoothness that can be customized.