With robust raw material testing and a comprehensive change control policy, these medical-grade concentrates and pre-colored formulations can help minimize risk and avoid non-compliance. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture. Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent implants, birth control devices, or plastic surgery.

PowerPoint Presentation MEDICAL DEVICE MANUFACTURER O S T O M Y B A G S E A L S • Comply with ISO 10993 and FDA Class II medical device regulations • Offer Good sealing performance • Provide technical supports for processing recommendations • Deliver a high compression set materials to improve comfort • Provided a medical-grade TPE to help the customer meet necessary regulatory specifications and gain market share • Provided technical support during design and the manufacturing process for EVA bonding • Delivered soft-touch feel and excellent sealing performance Versaflex HC Thermoplastic Elastomers - G2705 Formulation KEY REQUIREMENTS WHY AVIENT? https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers Slide 1: MEDICAL Device manufacturer

Mevopur™ Healthcare Functional Additives Laser Marking Additives for Medical Devices and Pharmaceutical Packaging Laser marking offers several advantages compared to other marking technologies. Potential applications include graduation markings for dose-dials, syringes and droppers, and serialization/coding (e.g., UDI) for medical devices and pharmaceutical packaging. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

Mevopur™ Healthcare Colorants and Formulations and Mevopur™ Healthcare Functional Additives for Bormed™ Resins Mevopur™ Healthcare Colorants and Formulations and Mevopur™ Healthcare Functional Additives help medical device, diagnostics and pharmaceutical packaging sectors meet the growing challenges of product consistency, compliance and reliability. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture. Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent implants, birth control devices, or plastic surgery.

Suitable for a variety of healthcare applications including medical tubing, devices, and equipment. Rubber Colorant Dispersions Provide optimal dispersion and lot-to-lot consistency to promote durability and ease of handling for medical devices and tools. Urethane Colorant Dispersions Streamline production and enhance quality to provide versatility for polyester and polyether urethane systems used in medical device applications.

Mevopur color and performance concentrates as well as ready-to-use formulations add value to a wide range of applications: MEDICAL DEVICES • Drug delivery • Catheters • Renal care/dialysis • Surgical instruments • Dental instruments • Medical device packaging • Electronic instruments and accessories for monitoring PHARMACEUTICAL PACKAGING • Vials, ampoules • Bottles for pills, liquid medicines • Blister packaging IN VITRO DIAGNOSTICS (IVD) • Blood analysis • IVD devices • IVD disposables (e.g., pipette tips) • Point-of-Care To meet various manufacturing processes, colorants and functional additives are provided as concentrates for dilution into the polymer or as ready-to-use formulations. Mevopur products cover the wide range of polymers and thermoplastic elastomers (TPEs) used in the medical and pharmaceutical sectors. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

AVIENT SOLUTION MEDICAL DEVICE MANUFACTURER C O M P R E S S I O N C O N T R O L L E R H O U S I N G G R I P • Good adhesion to PCTG • Comfortable grip combined with ergonomics • Medical regulation compliance • Provided a medical-grade TPE with excellent bonding to PCTG and good chemical resistance • Improved ergonomics and aesthetics with a soft- touch material • Met medical regulation compliance: FDA21 CFR 177.2600 • Delivered good colorability to ensure a stable esthetic KEY REQUIREMENTS OVERMOLDING + REGULATORY SUPPORT LEARN MORE Versollan Thermoplastic Elastomers Copyright © 2024, Avient Corporation. https://www.avient.com/products/thermoplastic-elastomers/versollan-thermoplastic-elastomers Slide 1: Medical Device manufacturer

The USee™ device will be part of the permanent collection at The Henry Ford Museum of American Innovation (Dearborn, Mich.), an IDSA partner. This award is proof that the USee™ device not only graduated but was the valedictorian. Avient’s design team assisted with the design, process analysis and production of the injection-molded plastic USee™ device, which includes a copolyester frame, medical-grade polycarbonate lenses, and acetal for the dials and gears.

By May 26, 2022, IVD device manufacturers who are not yet registered must be fully compliant with all changes set forth in the new regulation. Under the new IVD Regulation, device manufacturers can expect challenging timelines and a need for even further technical or regulatory documentation. Backed by robust bio-compatibility pre-testing, healthcare quality systems, and change control standards, these ‘medical grade’ concentrates and pre-color formulations can help minimize risk and avoid high costs of non-compliance.

The USee™ device will be part of the permanent collection at The Henry Ford Museum of American Innovation (Dearborn, Mich.), an IDSA partner. This award is proof that the USee™ device not only graduated but was the valedictorian. Avient’s design team assisted with the design, process analysis and production of the injection-molded plastic USee™ device, which includes a copolyester frame, medical-grade polycarbonate lenses, and acetal for the dials and gears.