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Product standards

Our product standards

The various SOFT product ranges are medical devices. They are manufactured according to the CE/Directive 93/42/EEC standard.

Quality production certificates are issued by:

  • SGS, which issues us the CE0120 standard
  • TÜV SÜD, which issues us the CE0123 standard
  • AGENCIA ESPANOLA DE MEDICAMENTOS, which assigns us the CE0318 standard
Our product standards
Our product standards
Our product standards

Our products also comply with the following standards:

  • EN ISO 13485:2012, EN ISO 13485:2013, and EN ISO 13485:2016

An annual audit is carried out at the production site by a notified body
(allows for the instruction and monitoring of the brand).

Inguinal granuloma increases the risk of HIV contamination. This characteristic is not specific to inguinal granuloma but to all STIs.

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Donovanosis is a tropical STI rapidly spreading in Europe. It is called the “flesh-eating disease.” It is a bacterial disease that attacks the immune system and can lead to sepsis. Like all STIs, it increases the risk of contracting HIV. Condoms remain the only effective prevention method. Antibiotic treatments are available to cure the disease.
It affects men more often. The ratio is 2 cases in men for every 1 in women. Transmission occurs during sexual intercourse (oral, vaginal, or anal).
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