Red&Blue Co., Ltd. Gets MDA for 'PAIN BOT' in Malaysia
Exports to Malaysia Expected to Accelerate Expansion in ASEAN Region Red&Blue receives approval to market 'PAIN BOT' as a medical device in Malaysia
Red & Blue, a company specializing in pain treatment medical devices, announced that it has obtained a medical device marketing authorization from the Medical Devices Agency (MDA) under the Ministry of Health of Malaysia for its 'PAIN BOT' medical device.
This is the result of an export agreement signed in February with Malaysia-based AdipoLABs Healthcare (Co-CEOs Moses and Isaac), a cooperative overseas partner of AdipoLABs (CEO Han Sung-ho), which has a successful export experience of 'High Frequency Hyperthermia Treatment Device Limitation 1℃'.
PAIN BOT is a class 2 combination medical device that combines low frequency and ultrasound developed by Red & Blue, which can detect painful areas and enhance treatment effectiveness through intensive treatment and management of painful points.
In particular, PAIN BOT, which is well-known overseas, is promoting export contracts to China, Vietnam, and Indonesia in addition to Middle Eastern countries such as Saudi Arabia and Bahrain, and export business progress has been accelerated in other ASEAN countries such as Indonesia, Vietnam, and the Philippines, starting with the approval of the Malaysian MDA medical device license for this PAIN BOTt device.
"Malaysia is the second largest medical device market after Thailand among major ASEAN countries," said Sung-cheol Yoo, General Manager of Red & Blue. "The ASEAN medical device market occupies a large size after Japan and China in the Asia-Pacific region, and is growing steeply with economic growth and population growth." He explained.
Founded in September 2017 in the New Material Industrial Complex in Godeok-myeon, Yesan-gun, Red&Blue received GMP certification in October 2020 and a medical device item license in December, obtained ISO 13485 (international certification), and received multiple patent applications and design registrations.
PAIN BOT can visualize painful areas and increase patient confidence and satisfaction through the objectification process of pain using a pain intensity measurement program, and can detect pain trigger points and help diagnose pain by measuring skin impedance (resistance).
"PAIN BOT is a device that can increase the satisfaction of pain patients in the actual medical field through visualization and objectification of invisible pain, and improve the quality of life by actually delivering health value," said Seung-mo Yoo, CEO of Red & Blue. said.
"Along with the domestic market in Korea, we will be able to leapfrog into a global export company, starting with the entry into Southeast Asian markets such as Malaysia." "We will continue to strive to promote K-Medical technology for pain treatment and management in Korea."