Sweden’s Medical Products Agency (Läkemedelsverket) has banned the sale of the PutOn condom brand in Sweden, claiming that the Chinese-manufactured product falsified its EU safety certification.
Accordingly, the agency ruled that the brand does not meet Swedish safety requirements after an inspection showed it falls short of the demands for the CE marking certifying that a product has met EU consumer safety, health or environmental requirements.
As a result, the agency advises against using the product.
“No freestanding organisation has examined the product, so no one knows if the condoms comply with standards. It is serious from a public health standpoint,” said investigator Gert Bruse to the TT news agency.
Malmö company Sibbarps International markets and sells the product in Sweden.
A representative from the company told The Local the company plans to appeal the decision, claiming it is based on “faulty information”.
The agency examined the contents of a certificate from an alleged certification body named TÛV SÛD. According to the certificate, the manufacturer of the product is a Chinese company called Yun Hai. According to the certificate, a German company is its authorised representative in Europe.
In a written declaration, TÛV SÛD testified that it does not know the Chinese company and that the presented certificate is a forgery.
According to vendor information on the internet, PutOn is sold both in three-packs and together with a vibrator ring, the latter marketed under the product name RockOn. Both products are available for sale in VendOn vending machines, which stock one or both products.
The agency’s decision to issue a sales ban on PutOn products applies whether they are sold separately or in combination with another product.