condoms CE mark certifications medical device

Condoms intended for sale or distribution within European Union must carry the CE mark, which verifies that the condom product meets the essential requirements of the medical device directive 93/42/EEC and 2007/47/EC. All the condom Manufacturers are required to follow specific conformity assessment procedures that include submitting a dossier to a European approved Notified Body. Compliance with ISO 4074 can be taken as evidence of compliance with the essential requirements of the medical device directive. Condom Manufacturing facilities are required to be ISO 13485 certified.

For personal safety and reliability reasons, it’s essential that the condoms have the same elasticity, resistance and have absolutely no holes. To make sure that each condoms manufacturer produces quality products, there are several norms and certificates to obtain to sell the condoms across the world. USA, UK, Canada, South Africa has their own standards, We have to get their local mark at first before enter into their markets.

As an ISO/CE approved condom company, welcome inquiry us to custom produce own brand condoms.

Email: sales8@oemcondom.com

WhatsApp: 0086-191-5379-1397

Contact: Rita