Expansion of Exports to Southeast Asia Expected to Accelerate with Singapore ApprovalRed & Blue Co., Ltd.’s PAIN BOT receives overseas approval in three countries: Malaysia, Indonesia, and now Singapore.
Red & Blue Co., Ltd., a company specializing in pain treatment medical devices, announced on Friday, the 25th, that its self-developed 'PAIN BOT' has received medical device market approval from the Medical Device Authority (MDA) under the Ministry of Health in Singapore.
Following the market approval in Malaysia in July 2023 and in Indonesia in May 2024, this latest approval in Singapore marks the third country in Southeast Asia where Red & Blue has secured regulatory clearance for PAIN BOT.
PAIN BOT is a Class II medical device developed by Red & Blue that combines low-frequency and ultrasound technology.
It detects pain points and delivers targeted treatment and management to maximize therapeutic effects. Additionally, it features pain visualization capabilities and a pain depth measurement program, enabling an objective assessment of pain. These features enhance patient trust and satisfaction.
The device also assists in pain diagnosis by detecting pain-inducing points through skin impedance (resistance) measurements.
PAIN BOT has been utilized in pain treatment research at various institutions, including the University of Cyberjaya (UOC) in Malaysia and the University Malaysia Sabah (UMS) in Kota Kinabalu, where multiple case studies have been reported on its effectiveness.
Since obtaining approval from the Malaysian Medical Device Authority (MDA) in July 2023, PAIN BOT has been supplied to a variety of pain clinics, hospitals, and medical institutions in Malaysia.
With the recent approval from Singapore’s MDA, Red & Blue anticipates accelerating its medical device export business in the Southeast Asian market.
Yoo Seong-cheol, General Manager at Red & Blue, stated, "Research conducted in collaboration with universities in various countries has demonstrated PAIN BOT's effectiveness, generating increasing interest overseas. With successful market entries in Malaysia, Indonesia, and now Singapore, we expect to firmly establish our presence in the Southeast Asian medical device market."
Yoo Seung-mo, CEO of Red & Blue, added, "To effectively treat patients' pain, it is essential to have tools that provide objective diagnosis and evaluation rather than relying solely on subjective assessments. PAIN BOT was developed through research on technology that objectifies, quantifies, and visualizes invisible pain. As global aging accelerates, the demand for such technology is expected to rise further."
Established in September 2017, Red & Blue expanded its factory located in the Shinsojae Industrial Complex in Godeok-myeon, Yesan-gun, Chungnam, obtaining GMP certification in October 2020.
In December of the same year, the company received medical device product approval and secured international certification for medical device quality management systems (ISO 13485). Additionally, Red & Blue holds multiple patent applications and design registrations.
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