Health Canada Medical Device Licence for Ceragem-RH
June 8, 2007

Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of all of Canada's people and to making this country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system.

The International Organization for Standardization (ISO) is a worldwide federation of national standard bodies from some 160 countries. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services in developing cooperation in the spheres of intellectual, scientific, technological and economic activity. ISO 9001:2000 specifies requirements for a quality management system for any organization that needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and aims to enhance customer satisfaction.

ISO 13485:2003 is a standard set by the International Organization for Standardization (ISO), and represents requirements for a quality management system in any organization that provides medical devices. In order to be certified for this standard, an organization must demonstrate its development, implementation and maintenance of a quality management system that meets customer and regulatory requirements while providing medical devices and related services.

Health Canada Medical Device Licence for Ceragem-C
February 13, 2003

Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of all of Canada's people and to making this country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system.

TUV Certified
October 29, 2003

TÜV (Technischer Überwachungsverein, English translation: Technical Inspection Association) is an accredited Management Systems Registrar in the US, Europe and Asia, providing ISO 9001, ISO 14001, ISO/TS 16949, QS-9000, TE Supplement, AS9100, VDA 6.1, EN 46000, ISO 13485/13488, TL 9000, OHSAS 18001 and ESD S20.20 certification services.

NOM Certified
July 25, 2003

Certifies that imported product is in compliance with NOM and NMX, Mexican standards.

UL Approved
July, 2001 (SMI-M3000)
April 15, 2002 (CGM-M3500)
November 2, 2006 (Ceragem-RH)

Underwriters Laboratories Inc. (UL) is an independent, not-for-profit product safety testing and certification organization. UL has tested products for public safety for more than a century. Each year, more than 17 billion UL Marks are applied to products worldwide.

U.S. Patented
June 5, 2001

The Patent and Trademark Office promotes industrial and technological progress in the United States and strengthens the national economy by first, administering the laws relating to patents and trademarks; second, advising the Secretary of Commerce, the President of the United States, and the administration on patent, trademark, and copyright protection; and last, advising the Secretary of Commerce, the President of the United States, and the Administration on the trade-relate aspects of intellectual property.

FCC Approved
October 13, 1999(SMI-M3000) and February 22, 2001(CGM-M3500)

The Federal Communications Commission (FCC) is an independent United States government agency, directly responsible to Congress. The FCC was established by the Communications Act of 1934 and is charged with regulating interstate and international communications by radio, television, wire, satellite and cable. The FCC's jurisdiction covers the 50 states, the District of Columbia and U.S. possessions.

FDA Registered
October 12, 1999

The FDA is an agency within the Department of Health and Human Services. The FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. The FDA's work is a blending of law and science aimed at protecting consumers.