The materials are produced under a third-party certified ISO 13485:2016 quality management system and backed by comprehensive change control of raw materials, formulation, and manufacturing standards to enable consistent batch-to-batch quality.”

¹PCF values are calculated with Avient’s TÜV certified PCF-Calculator according to ISO 14067.  

Mevopur™ Colorants represent a broad range of color concentrates and formulations, developed specifically for use in today’s complex healthcare applications, which meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661 and ICH Q3D.

These values were determined using Avient’s PCF Calculator, which is third-party certified by TÜV Rheinland and aligns with ISO-14067:2018 standards.

This is to certify that Fiber-Line, LLC 280 Performance Drive SE, Hickory, North Carolina 28602 USA Quality Management System ISO 9001:2015 Manufacture of textile components to cable manufacturers. Certificate No.: CERT-0116814 Original Certification Date: November 24, 2010 File No.: 1616267 Certification Effective Date: April 1, 2021 Issue Date: March 30, 2021 Certificate Expiry Date: March 31, 2024 ________________________________________________________________________________ ISO 9001 Registered by: QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.

H Y P O D E R M I C N E E D L E M A N U FAC T U R E R N E E D L E H U B , C O V E R A N D S H I E L D • Compliance to ISO 6009 color coding for single use hypodermic needle • Biocompatibility of all component materials • Good mechanical and visual properties after sterilization (e.g. ETO / Gamma radiation) • Facilitated 510(k) submission with formulations registered under Device Master File MAF 1833 • Pre-tested raw materials to biocompatibility ISO10993, US and Eu Pharmacopeia, ICH-Q3D extractable metals • Enhanced stability with gamma stabilizing package • Minimized risk of change with change control beyond CAS number level • Ensured uninterrupted supply from multiple ISO 13485-2016 certified sites • MEVOPURTM ISO 6009 Standard / Customized Solutions KEY REQUIREMENTS WHY AVIENT?

2 /J u n -2 0 1 9 /V er si o n 1 .0 Certificate Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate 618684 Singapore Singapore Scope Administration, Site management, Manufacture, Laboratory, Procurement, Maintenance, infrastructure, Warehouse and Transport Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45483 Validity 01. 03. 2022  – 28. 02. 2025 Issue 01. 03. 2022  A.Grisard, President SQS F.