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Xodus Quality Management System Certifications

ISO 13485:2016 Quality System Certification CE Mark MDD 93/42/EEC US FDA Good Manufacturing Practice (cGMP) 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.
© 2018 Xodus Medical Inc. All Rights Reserved.
+1 724.337.5500