EUROPE: Certification CE


    The Andro-Penis ® has been classified by the European Union Health Authorities as a Medical Device Type 1, and has the CE sign. ( Tests of approval were realized as establised in the declaration of Helsinki, adopted in 1964 during the 18th World medical Assemblee in Helsinki, Finland, and revised in 1989 during the 41st assamblee in Hong Kong).


    The Andro-Penis ® is made according to the standards of the European Union, using only medical parts of he highest quality, suitable for being in continuous contact with the human skintissue. It is produced using Quality Control Management with the UNE-EN ISO 9001:2000 standard and is certified by the Brtish Standards Institution - BSI.


    Andromedical ® is registred under the following Health Certification: D.A.P.S. 334/M, handed out in Europe by the Health Authorities of the Autonomous Region of Madrid, Spain.

 MEXICO


    The Andro-Penis®, is at present, the only medical device of its kind to be approved by the Federal Health Authorities of Mexico and by the Ministry of Health of each State of the Republic. In the State of Jalisco the permit number is: S.S.08Q03N. Our product is manufactured to comply with the highest medical standards and highest product quality that will enable our device to be in direct touch with the skin and mucous membranes for a prolonged period of time.

    The Andro-Penis® is classified as a Medical Device and obtains the Federal Certificate of Import SSA-04-003. ANDROMEDICAL MEXICO S.A. DE C.V. it is registered in the S.H.C.P. (Secretarìa de Hacienda y Crèdito Pùblico) with the R.F.C.(Registro Federal de Contribuyentes): AME010326 LC3.

 MERCOSUR


    The Andro-Penis ® is classified as a Medical Device. Our product is manufactured to comply with the highest medical standards and product quality that will enable our device to be in direct contact with the skin and mucous membranes of humans for prolonged periods of time.


    Our product complies with the Health specification of the countries of Mercosur (Argentina, Brasil, Uruguay, Paraguay and Chile)and is in the process of obtaining the Certification from the Departments of Health of such countries