Medical CE Approvals

Since June 13, 1998 it has been mandatory by law within the EU area for instruments and devices that are brought into the market in medical field / rehabilitation to have official approval according to European and other International standards. For medical devices including a measurement option, such as balance and muscle strength devices, this approval can only be achieved with the participation and cofirmation of an external offical notified body that has been certified to have this role. In the case of such devices the manufacturer can not simply decide by itself that the essential requirements are fulfilled. Keeping in the market or selling products that do not have the relevant approval is illegal.

Metitur USA is the only manufacturer and dealer that has the offical Medical CE Approval (Notified Body ID 0537, VTT Technical Research Centre of Finland) for balance and muscle strength devices delivered in the Nordic countries and several other market areas.

 



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Metitur USA | 221 Mill Valley Drive, Colleyville, TX 76034 | TEL: 888-498-7874, Fax: 817-428-1243 | sales@metiturusa.com