ISO 13485:2003 quality system certification
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations
Product Certifications and Approvals
AUSTRALIA- Medical device Licenses (Links to TGA website- www.ebs.tga.gov.au)
CANADA- Medical device licenses
Europe – CE Marking Certificates
EUROPE – Declarations of Conformity
United States- FDA 510 (k) cleared devices and Class I Exempt Devices
Global Regulatory Representatives
AUSTRALIA – Sponsor Representative
Emergo Australia PTY. LTD., Sidney, Australia
EUROPE – Authorized Representative
Emergo Europe, The Hague, Netherlands
UNITED STATES – US Agent Representative
Lifestream Purification systems, LLC
7303 Burleson Rd., Suite 801.
Austin, Texas 78744
NOTIFIED BODY/ REGISTRAR / CERTIFICATION BODY
LIFESTREAM PURIFICATIONS SYSTEMS, LLC maintains ISO 13485:2003 and is audited every year by:
BSI Management Systems America, Inc.
12110 Sunset Hills Road, Suite 200
Reston, VA 20190-5902
MATERIAL SAFETY DATA SHEETS for disinfectants used with the Angel of Water® CM-1 and Cherubum® Personal Hygiene System.