AdipoLABs’ high-frequency device ‘REMISSION 1℃’ is being exported to Europe
Market is diversified. Obtaining European CE certification is like stepping on a gas pedal. The device is ‘being recognized’ as one of the world’s leading high-frequency hyperthermia equipment.
▲ CEO Han Sung-ho
【Whosaeng】 AdipoLABs, a leader in high-frequency hyperthermia cancer treatment at Korea and abroad, has opened the way to export to Europe with its innovative high-frequency hyperthermia device ‘REMISSION 1℃’.
AdipoLABs Co., Ltd. (CEO Han Sung-ho) announced on the 8th that the company had obtained European CE certification. AdipoLABs has been working to diversify export markets to countries around the world, including China, Southeast Asia, India, and the Middle East.
Therefore, it is expected that the acquisition of European CE certification will accelerate the diversification of the export market for ‘REMISSION 1℃’ and help the company continue to stand as one of the key players in the world’s high-frequency hyperthermia market.
AdipoLABs has been preparing to obtain European CE certification since 2018. To this end, AdipoLABs applied for certification permission from domestic construction companies and MTIC, an international certification body based in Italy that certifies a wide range of systems, products and personnel that meet the requirements of international standards, European directives (CE marking) and national regulations.
However, there were many difficulties in obtaining European CE certification.
Starting from the first quarter of 2019, AdipoLABs collected data for European CE certification and submitted the data required by MTIC, including electromagnetic compatibility test samples, biological test samples, and RoHS samples.
It was certified through several supplements and rejections over the course of a year, and finally, after review by MTIC Italy in March, the final copy of the CE certification was delivered on August 8th.
▲ AdipoLABs' medical high-frequency hyperthermia device, REMISSION 1℃ (left) and the final copy of the European CE certification (right).
REMISSION 1°C, a high-frequency hyperthermia device that recently obtained European CE certification, acquired manufacturing permission from the Ministry of Food and Drug Safety in 2015, and received Halal certification, US FDA registration, ISO13485 certification, and Shariah certification in 2018. ) certification and RoHS certification.
Since January 2019, REMISSION 1°C has been introduced to the Catholic University of Korea's Seoul St. Mary's Hospital and has been used on patients, showing many clinical effects, proving the fact that the device is receiving enormous attention from the medical community.
' REMISSION 1℃' is a medical device that treats cancer and relieves pain by increasing our body temperature above 40℃, improving blood circulation and immunity through deep heat. The device captured a sensational attention from visitors from all around the world during 'Middle East and Asia Business Expo 2018⋅' held in October 2018 along with '35th KIMES’ that was held in March 2019.
In addition, on September 7th 2019, ' REMISSION 1℃' special seminar was held in Xi'an, Shaanxi Province, China, and in October of the same year, similar event was held in Samara, Russia for '2019 World Halal Day'. The equipment is receiving extraordinary attention in the markets of India and Malaysia at the moment, too.
▲Meeting with officials at a Malaysian university hospital (left) and the scene of ‘REMISSION 1℃ being operated at a Malaysian university hospital (right).
In particular, by obtaining this European CE certification, AdipoLABs has laid the foundation for export contracts by speeding up exports to Southeast Asia, India, Mauritius, and Romania. In Malaysia, with the help of European CE certification of ' REMISSION 1℃', the device can be approved immediately by the Ministry of Health (MDA) in the country. Sales are expected to be made to each hospital promptly by then.
‘REMISSION 1℃’ has been undergoing clinical trials on cancer patients at the University of Malaya Medical Center (UMMC) since June and is showing positive results. Based on clinical results, REMISSION 1℃ is expected to be approved as a cancer treatment medical device in Malaysia.
UMMC is a Malaysian semi-governmental hospital and the largest hospital in the country. Professor Ho Gwo Fuang, who is in charge of clinical practice, is academically recognized not only in Malaysia but also around the world.
In addition, Beacon Hospital, the largest private cancer center in Malaysia, is expected to purchase a large amount of ‘REMISSION 1℃’ quickly as the device has been approved with European CE certification, a company official said.
Regarding the acquisition of this European CE certification, CEO Han Sung-ho said, “Despite difficult conditions at home and abroad due to the COVID-19 incident, the European CE certification is expected to give momentum to the export of REMISSION 1℃ and with the export of medical devices, we will be able to contribute to the country and society by improving the national image and developing the medical market.”
Especially, for AdipoLABs, which was experiencing difficulties due to the COVID-19 incident, the acquisition of this European CE certification is raising expectations as a feat for advancing into the world's central stage.
Meanwhile, European CE certification is an integrated standard certification mark that means the product has satisfied all requirements of the EU Council Directive in relation to safety, health, environment, and consumer protection. CE marking on products is mandatory in order to sell products in the European Union (EU) market. The certification should be indicated upon sales.
Source: http://m.whosaeng.com/120025
