Artificial lung ventilation devices “AVENTA-M” can be approved for use only after additional verification of functional and technical characteristics

In connection with the introduction of changes to the documents contained in the registration dossier for the medical device “Artificial lung ventilation apparatus” AVENTA-M “according to TU 9444-004-07509215-2010 with accessories” produced by JSC “Ural Instrument-Making Plant” (registration certificate dated 19.02. 2016 No. FSR 2010/09268), Roszdravnadzor reports the following.

On July 21, 2020, the Federal Service for Surveillance in Healthcare issued a reissued registration certificate dated July 21, 2020 No. FSR 2010/09268 for the medical product “Artificial ventilation apparatus” AVENTA-M “version 01 according to TU 9444-004-07509215-2010 with accessories “, Produced by JSC” Ural Instrument-Making Plant “.

Please note that at present JSC “Ural Instrument-Making Plant” is taking corrective measures in relation to the AVENTA-M ventilator.

Thus, artificial lung ventilation apparatus “AVENTA-M” according to TU 9444-004-07509215-2010 with accessories “can be approved for use only after additional verification of functional and technical characteristics and obtaining the relevant documents, as indicated in the information letter of Roszdravnadzor” On recall of a medical product “dated 22.06.2020 No. 01I-1181/20.