Regulatory - GyneConcepts, Inc.

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Gyneconcepts Patent: US Patent No. 8,672,861 B2 / Issued Mar. 18, 2014
Gyneconcepts Patent: US Patent No. 8,460,209 B2 / Issued June 11, 2013
In Vitro Device Registration Notification (CE): IVD Device Registration Letter - 18 Mar 2016
Medical Device Registration Notification (CE): Medical Device Registration Letter - 18 Mar 2016
Authorized Representative (CE):

816 Congress Avenue, Suite 1400, Austin, TX USA 78701
+1-512-222-0262
www.emergogroup.com

This product is not approved for sale or use in the US.