Regulatory Approvals

The table below identifies the key regulatory approvals. Additional approvals have been received for individual markets.

For further information on specific approvals, please contact your local distributor.

Country Regulatory Body Approval
United States of America US Food and Drug Administration February 2011
Canada Health Canada September 2008
Sonex-HL – Drug Identification Number (DIN) March 2012
Europe TUVRheinland April 2008
Australia Australian Therapeutics Goods Administration February 2009
New Zealand Medsafe: New Zealand Medicines and Medical Devices Authority November 2008
 Russia    Federal Supervision for Healthcare and Social Development December 2009
Korea   Ministry of Food and Drug Safety August 2013
 Singapore   Health Science Authority December 2012
Hong Kong   Medical Device Control Office December 2012
Mexico   COFEPRIS October 2013