Regulatory

• About Us
• Medical Advisory
• Intellectual Property
• Regulatory

Uscom is committed to maintaining the highest standards in regulatory compliance prior to entry of each of its markets worldwide.

Australian regulatory clearance, a Certificate of Listing by the Therapeutic Goods Administration (TGA) was issued in November 2001 for the USCOM 1A.

In the United States USCOM 1A received the necessary regulatory clearance (FDA 510K notification) in February 2005. For Europe, Uscom received CE Mark certification in December 2003.

For China , Uscom has been issued regulatory approval by the State Food and Drug Administration (SFDA).

REGION	APPROVAL	STATUS	DOCUMENT
Registration	ASIC Business Registration		View Certificate
General	Quality (ISO 13485)	APPROVED	View Certificate
Australia	TGA Listing and Certificate	APPROVED	View Certificate View USCOM 1A ARTG View BP+ ARTG View SpiroSonic ARTG
Europe	USCOM 1A - CE Mark   BP+ - CE Mark   SpiroSonic - CE Mark	APPROVED   APPROVED   APPROVED	CE MDR Extension Letter View USCOM 1A Certificate USCOM 1A CE Extension Letter View BP+ Certificate BP+ CE Extension Letter View SpiroSonic Certificate
USA	USCOM 1A FDA 510K Notification BP+ FDA 510K Notification	RECEIVED   RECEIVED	View USCOM 1A K043139   View BP+ K121266