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?

BLOOD LANCET MANUFACTURER S E A L I N G R I N G • Compliance with strict regulations for medical materials • Excellent sealing performance • Good compression set • Provided a recycled TPE solutions compared to silicone without increasing system cost • Delivered a TPE that complied with ISO 10993-4 & -5 and USP Class VI • Supported a change to an injection molded material to ease production and enhance assembly capabilities Versaflex™ HC TPEs – OM1040-1 Grade 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?

A LIFE SCIENCE COMPANY S E R U M C O L L E C T I O N C A R T R I D G E • Excellent clarity • Good bonding and peel strength onto PP • Heat resistance • Meet sterilization needs • Easy processing • Formulated transparent Shore 50A TPE with excellent adhesion onto PP and good sealing performance • Met regulatory requirements for USP Class VI and ISO 10993-4,5 • Provided a short lead time and on-site technical service Versaflex™ CL Thermoplastic Elastomers KEY REQUIREMENTS WHY AVIENT?

View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 Certificate 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 Page 1 of 1 Validity 20. 01. 2024  – 19. 01. 2027 Issue 20. 01. 2024  A.Grisard, President SQS 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.

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.

ISO 10993 & USP Class VI compliant solutions

Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 14001:2015 The Environment Management System is applicable to: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.

Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau die Einführung und Anwendung eines Managementsystems gemäß DIN EN ISO 50001:2018 für den Geltungsbereich: Entwicklung und Produktion von technischen Thermoplasten; an den Standorten gemäß Anlage.