1 documents found
Information × Registration Number 0224U002948, 0123U105126 , R & D reports Title Sanitary and epidemiological evaluation: high-frequency welding electrocoagulator EKR300 dr Nic, high-frequency welding electrocoagulator MARK-AI. popup.stage_title Head Semashko Petro V., Доктор медичних наук Registration Date 18-03-2024 Organization State Institution "OM Marzeev Institute of Public Health of the National Academy of Medical Sciences of Ukraine" popup.description2 Sanitary and epidemiological assessment was carried out: high-frequency welding electrocoagulator EKR300 dr Nic, high-frequency welding electrocoagulator MARK-AI. Area of application and purpose: surgery. Principle of operation: connection (welding) of pre-cut soft biological tissues of animals and humans using high-frequency current. There are no special regulatory documents for this product, therefore, during the hygienic assessment, the standards in force in hygienic practice are used. The analysis of the principle of operation and technical characteristics of the product allow us to consider it a potential source of EMF. The device is made of traditional materials and structural elements approved for use, which are typical for products of this type. The information provided about the High-frequency welding electrocoagulator EKR300 dr Nic, manufactured in accordance with TU U 32.5-40167303-003:2022 and the High-frequency welding electrocoagulator MARK-AI, manufactured in accordance with TU U 32.5-40167303-001:2016 revision No. 2, should be considered sufficient to conclude that the products comply with the sanitary legislation of Ukraine, subject to compliance with the requirements. Product Description popup.authors Bezverkha Anna P. Semashko Petro V. popup.nrat_date 2024-03-18 Close
R & D report
Head: Semashko Petro V.. Sanitary and epidemiological evaluation: high-frequency welding electrocoagulator EKR300 dr Nic, high-frequency welding electrocoagulator MARK-AI.. (popup.stage: ). State Institution "OM Marzeev Institute of Public Health of the National Academy of Medical Sciences of Ukraine". № 0224U002948
1 documents found

Updated: 2026-03-25