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Biocompatibility Tests Ensure The Patients Safety

Andropenis reflects our penchant for perfection, being safe and effective. Amongst penis extenders, Andropenis is the market leader and for this we stand by our product with pride, as it is the only penis extender which holds biocompatibility tests to ensure the patient´s safety.

Driven by the desire for transparency, Andromedical makes its clinical test results publicly available. This is a proof of reliability, performance and safety for our customers.

Below you can find a brief description of what these tests are:

Cytotoxicity - a standardized test that is a very sensitive way to determine if the materials in that of a medical device contain any harmful components that can leak into the body or its cells.

Andropenis is NON-cytotoxic.

Hypersensitivity - Sensitization or hypersensitivity tests test for adverse reactions in the body by exposing the skin to the product or taking extracts from the products or its component materials and injecting and/or topically applying them to check for reactions. Sensitization reactions are noted by observing redness and swelling as components interact with the body's immune system.

Andropenis is NON-sensitizing.

Skin Irritation - Skin Irritation tests test the reaction to a single, repeated or continual exposure from device materials that may produce skin, mucosal, or eye irritation- a local tissue response characterization by the usual signs of inflammation- redness, and swelling, and could be accompanied by heat and pain. Different from sensitization in that it does not involve the immunological mechanism.

Andropenis is NON-irritant.

Click here to see a full description on our penis extenders.

Contraindications to use: Always consult your doctor before using the products if you suffer from uncontrolled diabetes, genital herpes, sexually transmitted diseases, urethritis and acute cystitis, acute prostatitis, abdominal hernia, dermatitis, testicular cancer, lymphatic cancer, lymphoma, paraplegics and quadriplegics. Also, before executing treatments or for a diagnosis of any medical condition, consultation with a licensed health care professional is strongly recommended.

Biocompatibility Tests - General Report
ISO 10993

Biocompatibility Hyper-sensitivity Test
ISO 10993-10:2002

Biocompatibility Skin Irritation Test
ISO 10993-10:2002

Biocompatibility Cyto-toxicity Test
ISO 10993-5:1999

Biocompatibility Heavy Metals Test
EN 71-3:2002

Biocompatibility Plastic Materials Test

Biocompatibility Mechanical Characterization Test

Biocompatibility Springs Characterization Test