Roszdravnadzor issued the first registration certificate for a medical device in the framework of the Eurasian Economic Union

The Federal Service for Supervision in the Field of Health informs about the issuance of the first registration certificate on December 31, 2019 within the framework of the Eurasian Economic Union for the medical product “Phototherapeutic Neonatal Radiator OFN-03, TU 9444-138-07539541-2015”, manufactured by JSC “UOMZ” (Russia).

This medical device is intended for the treatment of hyperbilirubinemia (jaundice) in newborns by reducing the concentration of indirect (unbound) bilirubin in the blood by irradiating the skin of a newborn with a light flux in the spectral range 430-530 nm (treatment range).

In addition, we inform that the Russian Federation was the reference state, and the Kyrgyz Republic was the state of recognition.