QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification (PDF format)
ISO 13485:2003 certificate
PRODUCT CERTIFICATIONS AND APPROVALS
CANADA- Medical device licenses (Links to Health Canada website - www.hc-sc.gc.ca)
All Devices
EUROPE - CE Marking certificates (PDF format)
All Devices
GLOBAL REGULATORY REPRESENTATIVES
Shown below are our in-country representatives for regulatory affairs issues and incident reporting.
EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com
UNITED STATES - US Agent representative
Lifestream Purification Systems, LLC
2001 South Lamar Blvd., Suite G, Austin, TX 78704
Telephone: 512.707.8383/www.angelofwater.com
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
Lifestream Purification Systems, LLC maintains ISO 13485:2003 certification and is audited every year by:
BSI Management Systems America, Inc.
12110 Sunset Hills Road, Suite 200
Reston, VA 20190-5902
Telephone: 1.800.862.4977
Fax: 703.437.9001
www.bsiamerica.com
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A portion of the proceeds from the sale of these products goes to charity. For our
mission statement, we invite you to visit www.lifestreampurification.com
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