Andromedical Health and Sanitary Certifications

Above all, as a medical laboratory Andromedical holds international certifications which guarantee the safe practice and hygienic certifications of the Andropenis. 

Each respective country founds particular guidelines in order to regulate Medical Companies in their manufacture and distribution of medical devices and Andromedical has adapted to these guidelines to ensure all patients the quality and excellence they expect.

The Andropenis is:

• Registered as a Class 2 Medical Device by the US FDA Health Authorities (as an external penile rigidity device).

• Classified by the European Union Health Authorities as a Medical Device Type 1 and carries the CE sign.

• Medically certified and carries the Medical Manufacturing License 5144-Ps

• Classified by the Australian Register of Therapeutic Goods (ARTG) as a Medical Device Included Class 1. ARTG ID: 154288

Here you can find a list of quality guarantees and health guarantees received from independent medical and quality institutions with regards to Andromedical and the Andropenis: