Production in ISO13485 certified sites with change control management

Biomerics manufactures its materials in ISO 13485 and FDA registered facilities in Salt Lake City, UT.

G E N O M I C D I AG N O S T I C D E V I C E M A N U FAC T U R E R I N - V I T R O D I A G N O S T I C ( I V D ) D E V I C E MEVOPURTM Laser-Transmitting and Laser-Absorbing Pre-color Solution AV I E N T S O L U T I O N • Customized solutions - Quality-by-Design (QdB) approach • Optimized pigment / additive selection – good distribution in final part minimizes welding failure • Mitigated contamination and extractable risk on incoming raw material with control based on fingerprinting • Ensured uninterrupted supply from multiple ISO13485-2016 certified sites • Minimized risk of change with change control agreements W H Y AV I E N T K E Y R E Q U I R E M E N T S P R O D U C T I V I T Y & Q U A L I T Y • Good weldability, low rejection rate • Solutions in wide range of polymers, colors and transparency • Pre-tested ingredients to biocompatibility and extractable metals L E A R N M O R E https://www.avient.com/products/polymer-additives/performance-enhancement-additives/mevopur-functional-additives

Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. validitystatement1: Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof. FACILITY1_LINE4: FACILITY1_LINE5: FACILITY1_LINE6: STANDARD: ISO 13485:2016 MANAGEMENT_TYPE2: The Quality Management System is applicable to: DATE_LABEL_1TF: DATE_VALUE_1TF: DATE_LABEL_2TF: DATE_VALUE_2TF: DATE_LABEL_3TF: Certificate No: DATE_VALUE_3TF: 54139 DATE_LABEL_4TF: Certification Date: DATE_VALUE_4TF: 04 September 2019 DATE_LABEL_5TF: Effective Date: DATE_VALUE_5TF: 01 September 2016 DATE_LABEL_6TF: Expiration Date: DATE_VALUE_6TF: 01 September 2022 DATE_LABEL_7TF: Revision Date: DATE_VALUE_7TF: 04 September 2019 MARK_3: MARK_2: SIGNATURE_NAME: Dominic Townsend, President SIGNATURE_IMAGE: 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 AUDIT_COMPLIANCE: MARK_1: SCOPE_DESCRIPTION: DESIGN, COMPOUND AND SUPPLY OF THERMOPLASTICS FOR THE MEDICAL DEVICE INDUSTRY.

Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. 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.

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.

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.

Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. 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). COMPOUND, SUPPLY AND PROTOTYPING SERVICES OF THERMOPLASTICS FOR THE MEDICAL DEVICE INDUSTRY Certificate Of Conformance

Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 65567 Effective Date: 08 September 2023 Expiration Date: 07 September 2026 Revision Date: 08 September 2023 Dominic Townsend, President This certificate may be found on the ABS QE Website (www.abs-qe.com). MANUFACTURE OF COLORANTS FOR PLASTICS FOR THE MEDICAL DEVICE INDUSTRY Certificate Of Conformance

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? AVIENT SOLUTION COLOR + CERTIFICATION LEARN MORE © 2021, Avient Corporation, All Rights Reserved https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/mevopur-custom-colors-and-formulations