MINISTRY OF PUBIC HEALTH, RUSSIAN FEDERATION COMMITTEE OF MEDICAL TECHNIQUE

Extract from Protocol No.2

Session of the Commission on instruments equipment and devices used in urology.

Heard : Study of materials and test specimen of urogenital "Uro-Biophon" apparatus for IR-therapy developed by the state enterprise "Izhevsky Engineering plant" to settle the question of recommendation for production.

1. Considering the results of testing and the statement on elimination of remarks pointed out in testing and submitted by the developer, the commission has recommended the apparatus developed by the state enterprise " Izhevsky Engineering plant" under a refined name "the Urogenital "Uro-Biophon" apparatus for IR-therapy" and designed for application in complex chlamydiosis treatment to be produced, recorded and entered in the state list for medical devices.
2. The apparatus shell be produced in conformity with a placed order.
3. The commission has called an attention of the developer and the coresearcher to working-out instructions for clinic application of the given apparatus with presentation of them given by the medical institutions performing clinical tests of the apparatus.
4. The commission considers that it can be advisable to discuss the question of further production of the "Uro-Biophon" apparatus for its reregistration within 10 years if the apparatus modernization is not provided ahead of schedule.