Confluent Now Offers Polyimide Tubing That Complies With REACH And EU Regulations
Chattanooga, TN- (June 12th, 2023)- Confluent Medical Technologies (Confluent), a leading medical device and materials science contract manufacturer specializing in high-precision polymer tubing, today announced the offering of REACH and EU Medical Device Regulation (MDR) Compliant Polyimide Tubing.
REACH, an acronym for Registration, Evaluation, Authorization, and Restriction of Chemicals, is an EU regulation that imposes stringent limitations on the amount of restricted substances that can be contained in devices sold in the EU. The industry standard polyimide, a material used extensively in medical applications such as vascular catheters, contains one of the restricted solvents.
“Historically, ensuring REACH compliance required extensive post processing to remove the residual solvent and even after this processing, compliance is not guaranteed,” stated Jill Ellison, VP of Site Operations for Confluent’s Polymer Tubing Center of Excellence. “Confluent’s REACH Compliant Polyimide is made with no restricted substances, therefore, there are no restricted solvents to remove and no extensive and expensive testing is required.”
Confluent’s REACH Compliant Polyimide uses industry standard chemistry resulting in product that looks and performs like traditional polyimide while avoiding the historical hurdles of ensuring EU compliance. Confluent is offering their REACH Compliant Polyimide immediately with lead times of 4 weeks or less.
About Confluent Medical
Confluent Applies Materials Science to MedTech Innovation. Confluent specializes in the expert design, development, and large-scale manufacturing of interventional catheter-based devices and implants. Customers rely on Confluent’s expertise in Nitinol material and components, balloon and complex catheters, high-precision polymer tubing, and implantable textiles. With facilities in Fremont and Orange County, California; Warwick, Rhode Island; Windham, Maine; Austin, Texas; Chattanooga, Tennessee; and San Jose, Costa Rica, Confluent has earned the confidence of the leaders in the medical device community through a proven track record of innovative materials science, engineering, and manufacturing. For more information, visit confluentmedical.com.