Van: RITM OKB ZAO
Verzonden: maandag 27 maart 2017
Dear friends and colleagues,
We are glad to inform you that we have got the renewed CE certificate.
As you might be aware the 3EC International a.s. notified body has recently conducted the certification audit at RITM OKB ZAO. We have successfully passed it and the Certificate No. 2017-MDD/QS-014 was issued. The audit has confirmed the compliance of our products with the European directive for medical products.
The personal, professional devices and add-on electrodes were again approved for distribution in the EU territory.
The CE certificate is a mandatory conformity mark for products marketed in the European Economic Area/Union (EEA/EEC). Having the CE mark means that the product meets the EU basic quality and safety requirements for the consumer.
Many other certificates (TGA, Cofepris etc.) giving the right for marketing the products in other countries are based on the CE mark.
Please note, that only the products purchased through the official RITM OKB ZAO distributors and representatives are properly cleared for the EU (as well as the US, Canadian, Australian, Mexican etc.) market and have all the necessary certificates and documentation, as well as the English interface, Operating Manual and User’s Instructions.
Dear SCENAR distributors, please pay attention to the Buyer Beware Note below and make your customers aware regarding the danger of purchasing from eBay (or any other e-shops or from the non-authorised distributors).
If you are looking for a SCENAR and see a variety of options from private sellers on eBay, Alibaba or Amazon, please note:
• Many of these units are fake and may not be genuine SCENAR devices (true RITMSCENARs are never cheap).
• Such devices are usually not properly cleared for the EU (as well as the US, Canadian, Australian, Mexican etc.) market and do not have all the necessary certificates and documentation, as well as the English interface, Operating Manual and User’s Instructions.
• It is a good chance the purchased second-hand SCENAR unit is not working properly.
• WE DO NOT offer any service, training, or support to the SCENAR devices purchased elsewhere.
• Neither the manufacturer nor official SCENAR representatives are responsible for any of the SCENAR devices purchased not from our authorized distributors.
• Only genuine RITMSCENARs with registered SN and purchased from the authorized distributors carry the original two years warranty.