Iso and CE certification condoms

The condom is a class IIb medical device and is subject to certain statutory provisions.

In Europe, the condom must meet the CE ISO 4074:2002 standard and must be packaged and/or stored in a warehouse with ISO 13485 certification.

The condom must always be packed with instructions for use and the aluminum foil must be protected by packaging. The packaging protects the condom and the instructions are on the inside or outside of the packaging.

The information must be legible and understandable for the user. The language specified in the instructions must be the language of the issuing country.

The content of the expiry date, the batch number, the number of the CE and the name and address of the manufacturer and / or importer of condoms must be visible in the envelope. The CE date, the expiry date and the LOT number must be stated on the foil of the condom.

We have relationships with various grades and legal services so manufacturers can better advise you.
The languages ​​of the manual.

Depending on the country where the condom packaging was issued, multiple languages ​​must be used for the instructions. In countries like Belgium or Switzerland, where more official languages ​​are often used, it is recommended to create the user manual in two languages. One language is sufficient for countries like Germany or France. For a general European export it is recommended to use German, English, Spanish and French in the manual.

We have our manual in different languages. If the language you want doesn’t exist, we can make sure that happens.

The space available on our envelopes for the indication of the legal information allows the use of a maximum of two languages.