PI and PI Glide Represent the First REACH and EU MDR Compliant Polyimide Tubing Available in the Global Market
Zeus Industrial Products, Inc. (Zeus), a leading polymer solutions provider and material science innovator, announced the first REACH and EU MDR compliant polyimide (PI) tubing, which is immediately available to the global market. The company verified compliance of its PI and PI Glide products through an independent lab.
An acronym for Registration, Evaluation, Authorisation and Restriction of Chemicals, REACH restricts the sourcing of harmful materials into the EU. The EU adopted this regulation to protect human and environmental health from chemical threats. REACH requires all companies to manage the risks linked to the substances they manufacture and market in the EU.
Referring to the European Medical Device Regulation, EU MDR ensures high standards of quality and safety for medical devices produced in or supplied into Europe. While REACH focuses on material composition, the more encompassing EU MDR regulation is specific to medical devices.
Polyimides are a class of high performing polymers known for their exceptional chemical, thermal and mechanical performance properties. They are used extensively in medical applications, especially in the construction of vascular and non-vascular catheters. Zeus offers a wide range of polyimide tubing products customizable in size, thickness, color and level of lubricity.
COMMENTS
“We understand our customers face regulatory burdens and we are committed to helping them overcome these challenges. Without a compliant PI supplier, companies may have to evaluate other materials or shelve plans to distribute products in Europe. Our compliant polyimide products not only provide peace-of-mind but can potentially save hundreds of thousands of dollars by avoiding material re-evaluation, product re-designs and launch delays.” – Bob Chaney, Senior Vice President, Global Sales & Marketing.
“Through continuous refinement and improvement of our manufacturing processes, Zeus is now able to provide REACH and EU MDR compliant polyimide tubing. We are the only supplier globally that can do this and achieving this compliance did not alter our end product in any way. Through extensive lab testing, Zeus has confirmed chemical structure and mechanical properties of the polyimide tubing products remain unaffected.” – Matt Allen, Senior Product Manager.
QUICK FACTS
- Zeus is the only supplier that can provide REACH and EU MDR compliant polyimide tubing, which is available immediately to the global market.
- REACH restricts the sourcing of harmful materials into the EU.
- EU MDR ensures high standards of quality and safety for medical devices produced in or supplied into Europe.
- Polyimides are used extensively in medical applications, especially in the construction of catheters.
- Zeus’ compliant PI and PI Glide products allow customers to avoid material re-evaluation, product re-designs and launch delays.
- Zeus offers a wide range of polyimide tubing products customizable in size, thickness, color and level of lubricity.
