SELF CPB-2000 passed the medical device manufacturing license performance test by the Ministry of Food and Drug Safety
Sanghan Kim, CEO of Dongseo Medicare “Securing safety according to ‘IEC 60601-1 Version 3.1’ for the first time in Korea”
[현대건강신문] At the KIMES (International Medical Equipment and Hospital Equipment Exhibition) held in March of this year, Celef CPB-2000, a ‘mobile’ high-frequency heater for cancer treatment, which attracted a lot of attention, obtained a manufacturing license from the Ministry of Food and Drug Safety (hereinafter referred to as the Ministry of Food and Drug Safety). did.
Sanghan Kim, CEO of Dongseo Medicare, which manufactures and sells SELF CPB-2000, said, “The mobile device CPB-2000 has also passed the same accreditation testing process as the CPB-1200. (Korea Research Institute of Chemical Convergence Testing) conducted a performance test and received a test report.”
Dongseo Medicare developed CPB-1100, a stationary high-frequency hyperthermia cancer treatment device, in 2016 with an emphasis on research and development of high-frequency heaters for cancer treatment.
Radiofrequency hyperthermia is a treatment that selectively applies high heat of 42 to 43 degrees to the tumor tissue to necrosis only the cancer cells.
In 1985, Professor Min-yong Park of Yonsei University College of Engineering conducted a study on the subject of ‘high-frequency hyperthermia system for treatment of heart disease,’ and predicted that the hyperthermia system would be a medical system that could be used for cancer treatment.
Dongseo Medicare, which has been investing in high-frequency hyperthermic cancer treatment equipment since 2016, has developed a new thermal cancer treatment device, the CPB-2000, that has △ miniaturization of equipment to increase mobility and patient convenience △ install a panel PC to increase the convenience of medical personnel △ The design that supports the electrode enhances stability, and △ movement is convenient and the fixation is strongly designed.
Sanghan Kim, CEO of Dongseo Medicare, said, “CPB-2000 is a 13.56MHz high-frequency device that has the most data and is the only mobile device in Korea. secured,” he said.
He continued, “At this year’s KIMES, hospital officials showed a lot of interest in the ‘mobile’ high-frequency hyperthermic cancer treatment device. The cost is also low, so we expect to expand the treatment portfolio of nursing hospitals.”
CPB-2000 has completed safety and performance verification in compliance with the KTR IEC 60601-1 Edition 3.1 standard, received approval for medical device manufacturing and quality control standards from the Gyeongin Food and Drug Administration, and obtained medical device manufacturing license from the Ministry of Food and Drug Safety. obtained