KEY CHARACTERISTICS • Manufactured under change control principles beyond CAS number (similar level as MEVOPUR concentrates), reducing risk of change • Free from animal-derived substances and phthalates • Suitable for blown film, injection molding, blow molding and extrusion REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP chapters , including Class VI, a requirement for ophthalmic and nasal drugs - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities - USP and USP light transmission • Registered Drug Master File (Type III) • Food contact compliance established with FDA/EU* APPLICATION BULLETIN CARRIER MATERIAL PIGMENT CONTENT/TYPE LIGHT FASTNESS THERMAL STABILITY PRODUCT CODE HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 Healthcare use limitations apply—see below. Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.

Mevopur™ Healthcare Colorants and Formulations for Needle and Catheter Hubs APPLICATION BULLETIN * FDA/EU compliance information available upon request To help our customers meet healthcare industry standards, Avient offers a range of standard colors for needle hubs, canula hubs and wings matching the color coding of the ISO 6009 standard. KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Color can be combined with additives to enhance performance and protection REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Device Master File • Food contact established with FDA/EU* NOMINAL OUTSIDE DIAMETER OF NEEDLE (MM) COLOR DESCRIPTION RAL PANTONE TRANSPARENT PRODUCT CODE OPAQUE PRODUCT CODE 0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127 0.45 Brown 8017 7588 C PP8M665294 PP8M665296 0.5 Orange 2003 173 C PP2M665298 PP2M665300 0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292 0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896 0.7 Black 9005 Black C PP9M664950 PP9M664952 0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689 0.9 Yellow 1021 115 C PP1M665211 PP1M665213 1.1 Cream 1015 7401 C PP0M665290 PP0M665292 1.2 Pink 3015 502 C PE3M665725 PP3M665727 Healthcare use limitations apply—see below.

主要特性 生产符合高于CAS编号级别的变更控制原则 （与MEVOPUR母粒类似），降低变更风险 不含动物源性物质和邻苯二甲酸盐 适用于吹膜、注塑、吹塑和挤出 注册药品主文件（III型） 食品接触符合FDA/EU*要求 法规支持 原材料根据以下法规测试： - ISO 10993-1 - USP第、章，包括VI级别，符合眼 科和鼻腔用药物要求 - 欧洲药典3.1.3/3.1.5（聚烯烃） - 美国药典（聚乙烯） - ICH Q3D 杂质元素 - USP和USP，透光率 载体材料 耐光性 热稳定性 产品代码颜料含量/类型 HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 适用医疗保健使用限制—见下文。 埃万特的产品不为以下目的或用途而设计，也不会宣传或预期用于以下目的或用途： (a) 被美国食品药品监督管理局（FDA）或国际标准化组织（ISO）归类为“植入”类器械的医疗器械；或美国药典（USP）或ISO标准定义的“永久”使用器械；或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46389 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 20. 12. 2023  A.Grisard, President SQS F.

Avient Colorants Germany GmbH Kornkamp 50 22926 Ahrensburg Germany Scope Production of Color- and Additives Concentrates, Compounds and Foaming Agents Normative base ISO 50001:2018 Energy Management System Reg. no. 46090 Validity 20. 01. 2021 – 19. 01. 2024 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Martorell no.124 08740 Sant Andreu de la Barca Spain Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46388 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 25. 02. 2024  A.Grisard, President SQS F.

Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau the introduction and application of a management system according to ISO 50001:2018 scope: Delelopment and production of technical Polymers; at the sites according to appendix.

Versaflex HC - Syringe Plunger - English SYRINGE MANUFACTURER D I S P O S A B L E S Y R I N G E P L U N G E R • USP VI and ISO 10993-4,5 compliant • Sterilize by gamma & EtO • Long-term sealing performance • Low coefficient of friction (COF) • Consistent performance across barrel sizes • Provided a formulated solution that met rigorous medical application requirements • Improved global supply continuity • Increased process efficiency by replacing previous thermoset material with TPE Versaflex™ HC 2110-57B KEY REQUIREMENTS WHY AVIENT?

Surgical instrument oem SURGICAL INSTRUMENT OEM E N D O S C O P E C O M P O N E N T S • Functional differentiation • ISO 10993 compliance • Excellent resistance to steam sterilization • Excellent chemical resistance • Delivered a variety of bright, distinguishing color choices for functional differentiation • Minimized color deviation • Provided a biocompatible solution • Offered low MOQ with flexible supply Transcend Premier PPSU Healthcare Pre- colored Solutions KEY REQUIREMENTS WHY AVIENT?

Martorell no.124 08740 Sant Andreu de la Barca Spain Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems Requirements for any organization in the food chain Reg. no. 46388 Validity 25. 02. 2021 – 24. 02. 2024 Issue 25. 02. 2021 Swiss Madesqs.ch F.