DEKRA Certification B.V.

jB.T.M. Holtus

¦J.A. van Vugt

Managing Director Certification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands

T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

CERTIFICATENumber: 3821156

The management system of:

SAFE-TEC® Clinical Products LLC142 Railroad DriveIvyland, PA 18974United States Of America

including the implementation meets the requirements of the standard:

ISO 13485:2016Scope:The design, manufacture and distribution of sampling and collecting devices for blood and blood components.

Certificate expiry date: 23 June 2023Certificate effective date: 23 June 2020Certified since: 23 June 2008