2 /Ju n- 20 19 /V er si on 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.

U KAS MANAC〔M〔N丁 SYSTEMS 0005 、端；薰；; HCSGS 13485 2016 Olin ：氨 城心〔找n心亡〔 ．．八 护、产、八 j丹月六户 八八月户 八月月‘、 ）如》 称资熨面蔚若三 「｛羹 StS55G S GSlfS5SG56SGSGSGSGSGSG5G5 f5 嚷i羹羹巍熊燕鬓；；奎忿 rage I Oil;；燕七 :终 sds 0Gs、 山5互 0s's""“ 刀之：J"‘、 ,slttiGsti.' China has been assessed and certified as meeting the requirements of 麟 ISO 13485:2016 EN ISO 13485:2016 ’骥鑫馨瓤） For the foiowing actratEes Design and manufacture of medical grade thermoplastic elastomers for non-active medical devices and active medical devices 遴；舞蒸；撇蒸 (non-implantable) ：护、：：于b入沙黔娜；舞睡莎：器器舞蟒檬非拟拐称群亘爸竺舀‘。

ABS Quality Evaluations This is to certify that the Quality Management System of: Avient Corporation Avient Corporation - McHenry, IL 831 Ridgeview Drive ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 45324 Certification Date: 24 February 2014 Effective Date: 13 January 2023 Expiration Date: 23 January 2026 Revision Date: 13 January 2023 Dominic Townsend, President DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE MEDICAL DEVICE INDUSTRY This certificate may be found on the ABS QE Website (www.abs-qe.com). WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations Avient Corporation ISO 13485:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.

Some have additional certifications such as ISO 13485, ISO 14000, ISO 22000 and other third-party certified standards such as Responsible Care® and IATF. https://www.avient.com/company/policies-and-governance/it-systems-use-policy 9 10 Annex 1 - ISO 13485 certification for Mevopur manufacturing sites North America & EMEA. Avient Colorants Sweden AB in Malmoe and Avient Colorants USA LLC in Lewiston, Maine are Medical Centers of Competence with an external ISO 13485 certification.

HYPODERMIC NEEDLE MANUFACTURER 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?

Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45484 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Homepage // News Center // PolyOne Specialty Coatings and Inks Kennesaw, GA Plant Achieves ISO 9001-2008 Certification CLEVELAND – PolyOne today announced that its Specialty Coating and Inks plant in Kennesaw, GA recently achieved ISO 9001-2008 certification. Kennesaw is the third plant in our Specialty Coatings business to achieve ISO 9001-2008 certification, joining our Mountain Top, PA and Long Beach, CA facilities,” Bindner said.

PHARMACEUTICAL PACKAGING OEM V I A L S , B O T T L E S & C O N T A I N E R S • Raw materials pre-tested to USP 661.1 and ICHQ3D guidelines • Stabilization during molding and sterilization processes for both opaque and transparent polymer materials • Certified formulations available globally • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the pharmaceutical value chain • Delivered specialized formulated solutions to meet stringent pharmaceutical packaging requirements • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Concentrates KEY REQUIREMENTS WHY AVIENT?

Some have additional certifications such as ISO 13485, ISO 14000, ISO 22000 and other third-party certified standards such as Responsible Care® and IATF. https://www.avient.com/company/policies-and-governance/it-systems-use-policy 9 10 Annex 1 - ISO 13485 certification for Mevopur manufacturing sites North America & EMEA. Avient Colorants Sweden AB in Malmoe and Avient Colorants USA LLC in Lewiston, Maine are Medical Centers of Competence with an external ISO 13485 certification.

ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 54139 Certification Date: 04 September 2019 Effective Date: 29 August 2022 Expiration Date: 01 September 2025 Revision Date: 29 August 2022 Dominic Townsend, President This certificate may be found on the ABS QE Website (www.abs-qe.com).