Normative basis EN ISO 13485:2016 Medical devices – Quality Management System Page 1 of 3 Appendix of main certificate H61173 Central function Scope Norm / Revision Reg. no.

Medical-grade colorant and functional additive masterbatches with robust bio-compatibility pre-testing to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce risk, increase appeal, and boost performance  Soft-touch, durable, and colorable TPEs that comply with USP Class VI, ISO 10993, and ISO 9001 for diverse overmolding needs, aesthetics, and haptics 

DATE 04/23/2020 DOCUMENT ID 202011402526 NAME RESERVATION (NRO) DESCRIPTION FILING 39.00 EXPED 100.00 CERT 0.00 COPY 0.00 Receipt Effective Date: 04/23/2020 180 East Broad Street, 16th Floor Columbus, OH 43215 (877) 767-6446 | (614) 466-2655 info@OhioSecretaryofState.gov www.OhioSecretaryofState.gov June 22, 2020 CT Corporation System Attn: Ken Brown 4400 Easton Common Way, Suite 125 Columbus, OH 43219 Re: Preclearance of Certificate of Amendment Dear: Mr.

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These include ISO pre-certified colorants; FDA-compliant materials from engineering thermoplastics and elastomers to vinyl, styrenics and olefins; RoHS and REACH compliant materials; and much more.

PLATINUM REGISTRATION INC. 1040 South Gaylord Street, Suite 71, Denver, CO 80209 www.platinumregistration.com | info@platinumregistration.com Polystrand, Inc. 8375 Highfield Parkway, Englewood, CO, 80112 Is certified by PLATINUM REGISTRATION as a company that has developed, implemented and maintains a quality management system that conforms to the requirements of the following International Standards: ISO 9001:2015 (Requirements not applicable:8.5.5 Post-delivery activities.) Certificate Number: 13132875 Certified Since: November 19, 2019 * Certificate Approval Date (Date Granted, Reduced, Extended, or Renewed): October 12, 2022 Current Certification Cycle Start Date: November 19, 2022 Current Certification Cycle Expiration Date: November 18, 2025 Rev: B This certification is subject to the organization maintaining its management system to the requirements of ISO 9001:2015 as well as the requirements of Platinum Registration, Inc.

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NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.