Certificate NEU Specialty Engineered Materials Certificate Of Conformance This is to certify that the Quality Management System of: NEU Specialty Engineered Materials 15 Corporate Drive North Haven CT 06473 United States has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 13485:2016 The Quality Management System is applicable to: Compounding, Prototype Services and Supply of Thermoplastics for the Medical Device Industry.

ISO 10993 & USP Class VI compliant solutions

CERTIFIED FOR ACCURACY AND RELIABILITY Our PCF Calculator is third-party certified by TÜV Rheinland and aligns with the ISO 14067:2018 standard for quantifying and reporting the carbon footprint of a product.

Avient Colorants Germany GmbH Hohenrhein 1 56112 Lahnstein Germany Scope Production of Color Concentrates and Compounds Normative base ISO 50001:2018 Energy Management System Reg. no. 46089 Validity 17. 12. 2020 – 16. 12. 2023 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Versaflex - CPAP tubing film CPAP TUBING C O R R U G A T E D T U B I N G F I L M • Replacement for polyolefins • Good spring-back • Bondable cuffs • Clear & clean look • Minimize humidity and condensation within the tube • No noticeable odor • FDA, ISO 10993 & USP VI compatible • Provided TPE solution to meet market expectations for improved user comfort & aesthetics • Reduced tube noise and improved drape compliance with new material solution versus polyolefins • Offered solution with improved thermal properties to combat humidity Versaflex™ CL2250 KEY REQUIREMENTS WHY AVIENT?

PRE-FILLED SYRINGE COMPANY S Y R I N G E T I P C A P • Excellent sealing performance • No DEHP or natural rubber latex added during processing • Can be sterilized by EtO • Compliant with ISO 10993-4&5 and USP Class VI • Formulated a solution that met rigorous medical application requirements • Leveraged global footprint to ensure supply continuity • Increased process efficiency by replacing previous thermoset material with a TPE Versaflex™ HC Thermoplastic Elastomers 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.

Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 46154 Validity 12.01.2022 – 11.01.2025 Issue 12.01.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland F.

WIRE &CABLE COMPANY O P T I C A L C A B L E S H E A T H • Excellent resistance to fungi and mildew • Good UV resistance • Meet flame retardant standard IEC 60332-3C • Provided an anti-fungi solution with an ISO 846 rating of 0, showing no growth under microscope • Formulated solution to meet flammability performance demands for IEC60332-2 or GBT 18380.22-2008 compliance • Complied with Biocidal Product Regulation (EU) No528/2012 (BPR) ECCOH™ Thermoplastic Formulation KEY REQUIREMENTS WHY AVIENT?