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Quality Management

 

Made in USAHealth CanadaCETL Mark CE Mark0086

 

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

Devices

Global Regulatory Representatives

AUSTRALIA – Sponsor Representative

Emergo Australia PTY. LTD., Sidney, Australia
Telephone: +61.2.9006.1662

EUROPE – Authorized Representative

Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570

UNITED STATES – US Agent Representative

Lifestream Purification systems, LLC
7303 Burleson Rd., Suite 801.
Austin, Texas 78744
Telephone: 1.512.707.8383
www.angelofwater.com

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
Telephone: 1.800.862.4977
Fax: 1.703.437.9001
www.bsiamerica.com

MATERIAL SAFETY DATA SHEETS for disinfectants used with the Angel of Water® CM-1 and Cherubum® Personal Hygiene System.