We have composite pellet manufacturing in North America and Europe guided by the ISO 9001:2015 certified quality system. 

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.

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 DOC ID ----> 202018203934 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.

They are available in certified USP Class VI and ISO 10993 compositions.

ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D and USP and evaluations reduce risk of non-compliance during regulatory submission​

OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified

All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.

This formulation meets the requirements of the ISO 15759 standard for medical infusion equipment, and can be steam autoclaved using temperatures up to 121°C.

Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications.

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