Certificate of Registration
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1 Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 & EN ISO 13485:2016 This is to certify that: STERIS Applied Sterilization Technologies 5960 Heisley Road Mentor Holds Certificate Number: MD and operates a Quality Management System which complies with the requirements of ISO 13485:2016 & EN ISO 13485:2016 for the following scope: in accordance with EN ISO 11135:2014. The provision of contract gamma and electron beam irradiation sterilization service in The provision of microbiological laboratory testing services associated with contract sterilization. For and on behalf of BSI: Stewart Brain, Head of Compliance & Risk - Medical Devices Page: 1 of 6
2 STERIS Applied Sterilization Technologies 5960 Heisley Road Mentor North Facility 1880 Industrial Drive Libertyville Illinois South Clinton Avenue South Plainfield New Jersey Isuzu Parkway Grand Prairie Texas Saint Andrews Avenue San Diego Isomedix Place El Paso Texas Group Level Headquarters. The provision of a contract gamma irradiation sterilization service in accordance with EN ISO :2015 with associated laboratory testing services. Page: 2 of 6
3 4405 Marketing Place Groveport Commerce Drive Libertyville Illinois th Avenue NW Minneapolis Minnesota Whitney Street Northborough Massachusetts S. Sarah Place Ontario South 150 East Sandy Utah The provision of contract gamma irradiation sterilization service in The provision of contract gamma and electron beam irradiation sterilization service in accordance with EN ISO :2015. Page: 3 of 6
4 2072 Southport Road Spartanburg South Carolina Business Park Drive Temecula Isomedix (Puerto Rico) Inc. State Road 690 KM 1.7 Barrio Sabana Hoyos Vega Alta Puerto Rico 9 Apollo Drive Whippany New Jersey Isomedix Corporation (Canada) 184 Crown Court Whitby Ontario L1N 7B1 Canada 23 Elizabeth Drive Chester New York The provision of a contract gamma sterilization service in The provision of a contract gamma sterilization service in Page: 4 of 6
5 1441 Don Haskins Drive El Paso Texas Activity Road Suite D San Diego West 4th Street Lima East 46th Avenue Drive Suite 100 Denver Colorado North Noah Drive Saxonburg Pennsylvania Synergy Health AST, SRL B16, Street 4, Avenue O El Coyol Free Zone El Coyol Alajuela Costa Rica sterilization service in sterilization service in sterilization service in sterilization service in sterilization service in Page: 5 of 6
6 Synergy Health AST, SRL B13.1 Street 4, Avenue 1 El Coyol Free Zone El Coyol Alajuela Costa Rica 3200 Lakeville Highway #120 Petaluma Isomedix Operations,Inc. 2 Nucifora Boulevard, Chester, New York, The provision of a laboratory testing service for the testing of biological indicators. The provision of contract electron beam sterilization service in The provision of a contract electron beam sterilization service in Page: 6 of 6
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