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1 Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2003 & EN ISO 13485:2012 This is to certify that: Sterigenics International, LLC Spring Road Suite 650 Oak Brook Holds Certificate Number: MD and operates a Quality Management System which complies with the requirements of ISO 13485:2003 & EN ISO 13485:2012 for the following scope: The provision of ethylene oxide and radiation sterilization services in accordance with EN ISO 11135:2014 & EN ISO :2015. Chemistry, microbiology and consulting For and on behalf of BSI: Stewart Brain, Head of Compliance & Risk - Medical Devices Page: 1 of 8

2 Sterigenics International, LLC 2015 Spring Road Suite 650 Oak Brook Sterigenics UK Limited Cotes Park Lane Somercotes Alfreton DE55 4NJ United Kingdom 4900 Gifford Avenue Los Angeles dba SteriPro Laboratories 687 S. Wanamaker Avenue Ontario Wichita Court Fort Worth Texas Olympic Industrial Drive SE Suite 116 Atlanta Georgia The provision of ethylene oxide and radiation sterilization services in accordance with EN ISO 11135:2014 & EN ISO :2015. associated laboratory services in accordance with EN ISO 11135:2014. Page: 2 of 8

3 10821 Withers Cove Park Drive Charlotte North Carolina W. Harold Gatty Drive Salt Lake City Utah Airport Road Santa Teresa New Mexico Park Road Queensbury New York Avenue T Grand Prairie Texas South Quincy Willowbrook Page: 3 of 8

4 344 Bonnie Circle Corona East Cooper Court Schaumburg Enterprise Drive Lewis Center Ohio Morgan Circle Tustin Lakeside Drive Gurnee Lincoln Avenue Hayward accordance with EN ISO :2015. accordance with EN ISO :2015. Page: 4 of 8

5 1148 Porter Avenue Haw River North Carolina Tilbury Road Salem New Jersey Obata Way Gilroy Lake Denmark Road Rockaway New Jersey College Blvd West Memphis Arkansas Formula Place San Diego accordance with EN ISO :2015. The provision of electron beam radiation services in accordance with EN ISO :2015. Page: 5 of 8

6 dba SteriPro Laboratories 1500 West Thorndale Avenue Itasca Sterigenics EO Canada, Inc. 781 Pharmacy Avenue Toronto Ontario M1L3K2 Canada Sterigenics S.de R.L. de C.V. Calle Norte 7 s/n Parque Industrial Tepeji Tepeji del Rio de Ocampos Edo. de Hidalgo CP Mexico Sterigenics (Thailand) Ltd. 109/16 Eastern Seaboard Industrial Estate (Rayong), Moo 4 T. Pluakdaeng A. Pluakdaeng, Rayong Province Thailand Withers Cove Park Drive Charlotte North Carolina Sterigenics Shanghai ETO Ltd. No. 333, Shuang Hui Road Yang Shan Free Port Shanghai China The provision of gamma irradiation in accordance with EN ISO :2015. associated laboratory services in accordance with EN ISO 11135:2014. Page: 6 of 8

7 Sterigenics Shanghai E Beam Ltd. A603 Lane 108 No. 588, Chuantu Road, Chuan Sha, Pudong Shanghai China Sterigenics Belgium (Fleurus) SA Zoning Industriel de Fleurus Avenue De L'Esperance Fleurus, Hainut B-6220 Belgium Sterigenics Germany GmbH Kasteler Straße 45 Wiesbaden, Hessen D Germany Sterigenics Belgium (Petit-Rechain) SA Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers, Liege B-4800 Belgium Sterigenics Denmark A/S Aa Louis-Hansens Alle 11 Espergaerde, Region Sjaelland DK-3060 Denmark Sterigenics SAS 8 Rue Parmentier Rantigny France The provision of electron beam irradiation and associated laboratory services in accordance with EN ISO :2015. The provision of gamma irradiation in accordance with EN ISO :2015. associated laboratory services in accordance with EN ISO11135:2014. associated laboratory services in accordance with EN ISO 11135:2014. The provision of electron beam irradiation and associated laboratory services in accordance with EN ISO :2015. associated laboratory services in accordance with EN ISO 11135:2014. Page: 7 of 8

8 Sterigenics Costa Rica S.R.L. Zona Franca PROPARK Calle Principal, Edificio 10 El Coyol Alajuela Costa Rica 687 S. Wanamaker Avenue Ontario Stergenics S.de R.L. de C.V. James Watt No. 22 Parque Industrial Cuamatla Cuautitlan Izcalli Edo. de Mexico CP Mexico Sterigenics U.S., LLC 502 Prairie Mine Road Mulberry Florida The provision of ethylene oxide sterilization services in The provision of ethylene oxide sterilization services in Provision of radiation sterilization services of medical devices to include requirements of EN ISO :2015. Page: 8 of 8

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