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
General Quality
(ISO 13485:2003)
APPROVED View Certificate
Australia TGA Listing and Certificate APPROVED

View Certificate

View USCOM 1A ARTG

View BP+ ARTG

Europe

USCOM 1A - CE Mark

BP+ - CE Mark

SpiroSonic - CE Mark

APPROVED

APPROVED

APPROVED

View USCOM 1A Certificate

View BP+ Certificate

View SpiroSonic Certificate

US

USCOM 1A FDA 510K

BP+ FDA 510K

RECEIVED

RECEIVED

View USCOM 1A K043139

View BP+ K121266

Canada Canadian Listing APPROVED View License
China CFDA Number APPROVED View Certificate
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