For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

We can help tackle your toughest challenges with our • In-depth industry knowledge • Expansive material solutions • Far-reaching technical capabilities and services Avient Corporation 4 1 Injection window Integrated rigid needle shield 2 Cap 3 1. Pigments and eye-catching special effects • Prompt, precise and custom color matching • Biocompatible functional additives • FDA CFR 21, USP VI, ISO 10993-X, and/or USP 661-X • ISO 13485 facilities Avient Corporation 5 4. Requirements: Skin contact colorant certified for ISO 10993 biocompatibility OnColor™ HC Plus, MEVOPUR® 5.

Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)

Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)

PLATINUM REGISTRATION INC. 1040 South Gaylord Street, Suite 71, Denver, CO 80209 www.platinumregistration.com | info@platinumregistration.com Polystrand, Inc. 8375 Highfield Parkway, Englewood, CO, 80112 Is certified by PLATINUM REGISTRATION as a company that has developed, implemented and maintains a quality management system that conforms to the requirements of the following International Standards: ISO 9001:2015 (Requirements not applicable:8.5.5 Post-delivery activities.) Certificate Number: 13132875 Certified Since: November 19, 2019 * Certificate Approval Date (Date Granted, Reduced, Extended, or Renewed): October 12, 2022 Current Certification Cycle Start Date: November 19, 2022 Current Certification Cycle Expiration Date: November 18, 2025 Rev: B This certification is subject to the organization maintaining its management system to the requirements of ISO 9001:2015 as well as the requirements of Platinum Registration, Inc. To verify this certificate please call 303-639-9001 *Transferred to Platinum Registration, Inc. on November 1, 2019.

Avient Site in Glendale, Arizona Earns ISO 13485 Certification The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutio

Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)

Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)

Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)

Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)