Certificate of Registration
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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 2015 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 :2007 & EN ISO :2006. Chemistry, microbiology and consulting services for the sterilization industry. For and on behalf of BSI: Gary Fenton, Global Assurance Director Page: 1 of 8
2 Sterigenics International, LLC 2015 Spring Road Suite 650 Oak Brook Sterigenics UK Limited Cotes Park Estate 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 Smyrna Georgia The provision of ethylene oxide and radiation sterilization services in accordance with EN ISO :2007 & EN ISO :2006. 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 Westerville Ohio Morgan Circle Tustin Lakeside Drive Gurnee Lincoln Avenue Hayward 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 The provision of electron beam radiation services in 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. dba SteriPro Laboratories James Watt No. 22 Parque Industrial Cuamatla Cuautitlan Izcalli Edo. de México CP Mexico 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 The provision of gamma irradiation in accordance with EN ISO :2006. Page: 6 of 8
7 Sterigenics Shanghai ETO Ltd. No. 333, Shuang Hui Road Yang Shan Free Port Shanghai China Sterigenics Shanghai E Beam Ltd. No. 588, Chuantu Road, Chuan Sha, Pudong Shanghai China Sterigenics Belgium (Fleurus) SA Zoning Industriel de Fleurus Avenue De L'Esperance Fleurus B-6220 Belgium Sterigenics Germany GmbH Kasteler Straße Wiesbaden Germany Sterigenics Belgium (Petit-Rechain) SA Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers B-4800 Belgium Sterigenics Denmark A/S Aa Louis-Hansens Alle 11 Espergaerde DK-3060 Denmark Sterigenics SAS 8 Rue Parmentier Rantigny France The provision of electron beam irradiation and associated laboratory services in The provision of gamma irradiation in accordance with EN ISO :2006. The provision of electron beam irradiation and associated laboratory services in 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 SAS Avenue de Lossburg Anse France The provision of ethylene oxide sterilization services in The provision of ethylene oxide sterilization services in Page: 8 of 8
EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
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Certificate of Registration
Certificate of Registration ENVIRONMENTAL MANAGEMENT SYSTEM - ISO 14001:2004 This is to certify that: 2200 West Salzburg Road 48686 Holds Certificate No: EMS 96453 and operates an Environmental Management
Certificate of Registration
Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 9001:2008 This is to certify that: 2200 West Salzburg Road P.O. Box 994 Holds Certificate No: FM 10734 and operates a Quality Management System
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