NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.

质量管理体系认证认证 证书编号：04624Q15809R1S 兹证明: 法博莱恩纱线（常州）有限公司 统一社会信用代码：91320412MA1NMF5W4P 质量管理体系符合: GB/T 19001-2016 / ISO 9001:2015 标准 证书覆盖范围: 纺织品（纱线）、玻璃制品（纱线）的包覆加工 注册地址/实际地理地址：江苏省常州西太湖科技产业园兰香路 8 号研发车间 5 厂房 颁证日期：2024-10-26 有效期至：2027-10-25 初次颁证日期：2021-10-28 证书编号 受审核方 组织机构代码 认证范围 注册地址 生产办公地址 注册日期 有效期至 初次颁证日期 二维码

Limited PO Box 2137, Jeddah 22758, Saudi Arabia Has been assessed and found to meet the requirements of ISO 45001:2018 This certificate is valid for the following scope of operations: Production and Supply of Color and Additive Master Batches Authorised by: Stan Wright Director Date of Certificate Issue: 30 December 2021 Certificate Valid Until: 29 December 2024 Recertification audit before 30 November 2024.

Francisco Nakasato, 1700 Bairro São Roque das Chaves Itupeva, SP 13295-000 Brasil ISO 9001:2015 O Sistema de Gestão da Qualidade é aplicável a: Certificado No: 49862 Data de Expiração Anterior: 09 Abril 2020 Data de Aprovação Original: 16 Abril 2014 Data de Certificação: 13 Abril 2020 Data Efetiva: 06 Abril 2023 Data de Expiração: 09 Abril 2026 Data de Emissão: 06 Abril 2023 Dominic Townsend, Presidente DEVELOPMENT, PRODUCTION, SALES AND TECHNICAL ASSISTANCE OF LIQUID COLORANTS, COLORS CONCENTRATES AND ADDITIVES FOR THE PLASTICS, FIBERS AND RUBBER MARKET IN GENERAL DESENVOLVIMENTO, PRODUÇÃO, VENDAS E ASSISTÊNCIA TÉCNICA DE COLORANTES LÍQUIDOS, CONCENTRADOS DE CORES E ADITIVOS PARA O MERCADO DE PLÁSTICOS, FIBRAS E BORRACHAS EM GERAL.

NEEDLE HUB MANUFACTURER N E E D L E H U B C O L O R S • RAL and Pantone® colors available in palette to align with ISO 6009 color standard • Opaque and transparent polypropylene selections available in both masterbatch and ready-to-use precolors • Raw materials pre-tested to ISO 10993 and USP Class VI medical device guidelines • Certified formulations available globally • Provided RAL and Pantone colors as required • Developed custom polypropylene formulations to meet specific opacities • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the value chain • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Colors KEY REQUIREMENTS WHY AVIENT?

Certificate - ISO 9001 - Avient Corporation - 337726 - 23521672 (1).pdf

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?

They provide comparable performance to 100% virgin equivalents and can help reduce product carbon footprint (PCF), which can be quantified on request using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067.   

Developed with the rigorous demands of the healthcare industry in mind, these innovative pre-colored compounds are formulated with materials that have been successfully tested for ISO 10993 biocompatibility, supporting compliance with the highest standards for medical applications.

Product Carbon Footprint values are calculated with Avient’s third-party certified PCF Calculator by TÜV Rheinland according to ISO 14067.