To whom it may concern

September 26, 2022

Subject: Biocompatibility P3001

Dear Customer:

Thank you for your interest in our products.

Covestro Additive Manufacturing has developed a material Addigy P3001 for use in a variety of applications, and has been tested on test article Prod: 2022, March, Batch ID-X1264 for ISO 10993-5 cytotoxicity, ISO 10993-10 Irritation & Sensitization.

Covestro Additive Manufacturing declares to be cooperative now and in future, in making the test reports relating to above mentioned safety testing available to national authorities and/or certification bodies on their request. Customer will make such a request known to Covestro Additive Manufacturing and will provide the contact information of mentioned authorities where the information can be sent. In all circumstances these reports will be treated confidential.

It concerns the following reports:

• ISO 10993-5 cytotoxicity

o Reference report: 22-B4185-G1

• ISO 10993-10 Irritation & Sensitization

o Reference report: 1507986-S01

o Reference report: 22-00609-G1

This letter is provided by Covestro Additive Manufacturing to the customer on
courtesy and solely for reason of transparency. Hence, Covestro Additive
Manufacturing makes no representation or warranty for any conclusion as to the
fitness for use in any particular application (purpose), nor accepts any liability in
respect of this purpose. This summary does not prevent customer from, nor

The information contained herein is believed to be accurate as of the date of this document. If any of the above mentioned regulations change after the date of declaration, this information is no longer valid.

The manner in which you use our products, technical assistance and information (whether verbal, written or by way of production evaluations), including any suggested formulations and recommendations, are beyond our control. Therefore, it is imperative that you test our products to determine suitability for your processing and intended uses. Your analysis must at least include testing to determine suitability from a technical, health, safety, and environmental and regulatory standpoint. Such testing has not necessarily been done by Covestro, and Covestro has not obtained any approvals or licenses for a particular use or application of the product, unless explicitly stated otherwise. If the intended use of the product is for the manufacture of a pharmaceutical / medicinal product, medical device or of precursor products for medical devices or for other specifically regulated applications which leads or may lead to a regulatory obligation of Covestro, Covestro must explicitly agree to such application before the sale.

Unless we otherwise agree in writing, all products are sold strictly pursuant to the terms of our standard conditions of sale which are available upon request.

Covestro (Netherlands) B.V.
Urmonderbaan 22
6167 RD Geleen
The Netherlands

All information and including technical assistance is given without warranty or guarantee and is subject to change without notice. It is expressly understood and agreed by you that you assume and hereby expressly release indemnify us and hold us harmless from all liability, in tort, contract or otherwise, incurred in connection with the use of our products, technical assistance, and information. Any statement or recommendation not contained herein is unauthorized and shall not bind us. Nothing herein shall be construed as a recommendation to use any product in conflict with any claim of any patent relative to any material or its use. No license is implied or in fact granted under the claims of any patent.

This information is exclusively for our customers and respective competent authorities. It is not intended for reproduction either in printed or electronic form (e.g. via internet) by others. Thus, neither partial nor full reproduction is allowed without written permission from Covestro.

replaces accomplishment of all relevant testing pursuant legal and regulatory
requirements.

Joanna Marguier

Dr. Dipl.-Ing. Joanna Marguier

Global Technical Product Manager Thermoplastics