Products Solutions Education OEM About Contact Search About Us Company Information Our Mission Quality Assurance Regulatory Compliance Contact Us Privacy Policy Xodus Quality Management System Certifications ISO 13485:2016 Quality System Certification Certificate CE Mark MDD 93/42/EEC Annev V Annev Vs US FDA Good Manufacturing Practice (cGMP) Establishment Registration CFG Export Certificate Xodus Medical, Inc. is fully compliant with Title 21 CFR Part 820, US FDA Quality Systems Regulations Notified Body / Registrar/ Certification Body Xodus Medical, Inc. maintains ISO 13485:2016 certification and is audited for compliance by: LNE-GMED 1 rue Gaston Boissier 75724 Paris Cedex 15 Xodus Medical, Inc. maintains CE Mark certification and is audited for compliance by: LNE-GMED 1 rue Gaston Boissier 75724 Paris Cedex 15 Xodus Medical, Inc. maintains US FDA Title 21 CFR 820 and is audited for compliance by: US FDA Philadelphia District Pittsburgh Resident Post 7 Parkway Center, Room 250 Pittsburgh, PA 15220 Authorized European Representative Emergo Europe Prinsessegracht 20 2514 AP The Hague Netherlands Telephone: +31 70 345 8570 https://www.emergobyul.com/services/europe Countries Xodus Currently Exports To Australia, Austria, Brazil, Canada, Chile, Denmark, Emirates, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, South Korea, Switzerland, Thailand, Turkey, United Arab and United Kingdom. Material Safety Data Sheets Supplied upon request. Manufacturer Warnings: Reuse of single use devices is prohibited due to the risk of cross contamination and/or infection. +1 724.337.5500 ◾ Privacy Policy ◾ Sitemap © 2021 Xodus Medical Inc. All Rights Reserved.