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EUROPE: Certification CE
The RXPenisEnlarger ® 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 established in the declaration of Helsinki,
adopted in 1964 during the 18th World medical Assembly in
Helsinki, Finland, and revised in 1989 during the 41st assembly
in Hong Kong).
The RXPenisEnlarger ® 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 skin tissue.
Andromedical ® is registered
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 RXPenisEnlarger®, 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 RXPenisEnlarger® 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 RXPenisEnlarger ® 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
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If you have or suspect an illness or have a health concern, always consult with your physician or health care provider. We have used our best judgment in compiling this information, however, the information presented may not have been evaluated by the Food and Drug Administration. Any reference to a specific product is for your information only and is not intended to diagnose, treat, cure, or prevent any disease.
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