They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need   Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring

Through this data, we create safety data sheets, customer certification statements for appropriate use and product safety improvements. Combined, these facilities have a total of 205 certifications to an ISO or Management System and standards. For our sensitive applications, in addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing Processes (GMP). 100% of our facilities producing those sensitive applications and warehouses are GMP audited within a 3–year period.

IATF Certificate Place and date: For the issuing office: Katy, TX, 22 May 2025 Revision 10 DNV - Business Assurance 1400 Ravello Drive, Katy, TX, 77449- 5164, USA Sherif Mekkawy Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. ACCREDITED UNIT: DNV Business Assurance USA Inc., 1400 Ravello Drive, Katy, TX, 77449-5164, USA - TEL: +1 281-396-1000. www.dnv.com Page 1 of 2 MANAGEMENT SYSTEM CERTIFICATE Certificate no.: 11229-2006-CHN-IATF IATF Certificate No: 0573810 Valid: 21 May 2025 – 20 May 2028 This is to certify that the management system of PolyOne - Suzhou, China EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China 215024 (USI: CF4943) and, if applicable, the remote supporting locations as mentioned in the Appendix accompanying this Certificate has been found to conform to the Quality Management System standard: IATF 16949:2016 This certificate is valid for the following scope: DESIGN AND MANUFACTURE OF PLASTIC COMPOUNDING MATERIAL EXCLUSION: NONE http://www.dnv.com Certificate no.: 11229-2006-CHN-IATF IATF Certificate No: 0573810 Place and date: Katy, TX, 22 May 2025 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. ACCREDITED UNIT: DNV Business Assurance USA Inc., 1400 Ravello Drive, Katy, TX, 77449-5164, USA - TEL: +1 281-396-1000. www.dnv.com Page 2 of 2 Appendix to Certificate PolyOne - Suzhou, China Remote Support Locations included in the certification are as follows: Site Name Site Address RSL Activities Certification Body Avient China Co., Ltd.

The issuing Certification Body is responsible for the accuracy of this document. Version / Date: 1 (no adjustments) / 30.12.2024 Page 1 of 2 ISCC PLUS Certificate Certificate Number: ISCC-PLUS-Cert-PL214-26100824 Bureau Veritas Polska Sp. z o.o. ul. Migdałowa 4, 02-796 Warszawa, Polska certifies that AVIENT Luxembourg S.à.r.l 14 Avenue de l’Eguillette, 95310 Saint Ouen L’Aumône FRANCE (operating under a tolling agreement) complies with the requirements of the certification system ISCC PLUS (International Sustainability and Carbon Certification) This certificate is valid from 30.12.2024 to 29.12.2025.

PCF values are calculated using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067

MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

They are tested to ISO 10993 standards, and can be customized with the addition of functional additives to enhance product performance.

Tested to ISO 10993

Avient follows the ISO 14067:2018 standard to calculate PCF values and utilizes global formulation expertise, green manufacturing processes, and sourcing & logistics competence to achieve such low or negative values.  

Dedicated global technical centers and ISO 13485 certified manufacturing sites round out the service offer and provide consistent support for diagnostic devices.