Our range of condoms, lubricating gels and probe covers are a medical devices, manufactured according to EC standard-(directive 93/42EEC)
Mandatory marking in the addition of standards:
- ISO 9001 : 2008
- ISO 13485 : 2003
- EN ISO 13485 : 2012
An annual audit of our production plant by a notified body allows the appraisal and monitoring of the brand.
The notified body SGS issued a quality certificate of production allowing the CE0120