European CE certificate for AdipoLABs’ medical high-frequency hyperthermia device REMISSION 1℃

[News In] Reporter Cho Jin-seong = REMISSION 1℃, a medical high-frequency hyperthermia device from AdipoLABs Co., Ltd., a leader in high-frequency hyperthermia devices at home and abroad, obtained European CE certification as of June 18th.

This laid the foundation for exports not only to Europe but also to Islamic countries and Southeast Asian markets.

AdipoLABs Co., Ltd. (CEO Han Sung-ho) has been preparing to obtain European CE certification since 2018. To this end, acquisition is a valuable result obtained by applying for certification permission from a domestic consulting company 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.

AdipoLABs, which had suffered through numerous improvements and rejections over two years, finally received European CE certification and acquired the final copy of the CE certification on August 8th.

European CE certification is an integrated standard certification mark that means that the device satisfies all the requirements of the EU Council Directive in relation to safety, health, environment, and consumer protection. CE is mandatory for products to be sold in the European Union (EU) market and in countries that recognize it. The CE marking must be displayed on the product.

REMISSION 1°C, a high-frequency hyperthermia device, obtained manufacturing permission from the Ministry of Food and Drug Safety in 2015 while receiving Halal certification, US FDA registration, ISO13485 certification, Shariah certification, and RoHS certification in 2018.

REMISSION 1°C, which is being used in about 80 medical institutions across the country, was introduced to the Catholic University of Korea's Seoul St. Mary's Hospital in January 2019 and has been used on patients, showing many clinical effects and attracting interest and 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 the attention of domestic and foreign medical officials from 'Middle East and Asia Business Expo' in October 2018 and '35th International Medical Equipment and Hospital Equipment Exhibition (KIMES 2019)' held in March 2019..

REMISSION 1°C, which is receiving more favorable reviews overseas, is drawing a lot of attention from the Malaysian medical community, especially with the acquisition of CE certification. According to an official from AdipoLABs, Malaysian local partners are gaining momentum with CE certification in obtaining approval in their country.

Beacon Hospital, Malaysia

In particular, REMISSION 1℃ has been installed at Beacon Hospital Sdn Bhd, one of the largest cancer centers in Malaysia and is providing training to local medical personnel.

(Clockwise from top) At Beacon Hospital, Malaysia, the attending physician, Dr. With Azura Rozila Ahmad

A view of a business meeting. Equipment demonstration by Malaysian partners Moses Balagopal and Isaac Joseph. AdipoLABs Malaysia local staff training on equipment use

It was reported that since June, REMISSION 1℃ has been undergoing clinical trials on cancer patients at the UMMC University of Malaya Medical Center and is showing positive results. Based on CE certification and clinical results at UMMC, REMISSION 1℃  is expected to be approved as a cancer treatment medical device in Malaysia.

(From top to bottom) Hospital officials and Adipo LABs executives and staff after a meeting at Beacon Hospital in Malaysia. After installing the hospital equipment, the doctor in charge, Dr. Photo of Azura Rozila Ahmad (center) with local staff Moses Balagopal and Isaac Joseph.

Officials said that it is expected that large quantities of REMISSION 1℃ will be purchased in Malaysia within a short period of time.

CEO Han Sung-ho said, "Despite difficult conditions at home and abroad due to the COVID-19 incident, the medical high-frequency device, REMISSION 1℃ with European CE certification served as an export bridgehead in Malaysia, enhancing the national image through medical device exports and advancing the medical market, further improving the country and society. He expressed his expectations, saying, “I will be able to contribute to this.”

Source: Newsin (http://www.newsin.co.kr)