Sinopex, the only company in Korea domesticating hemodialysis machines, is showing strong performance following the news that it has become the first to receive international certification (ISO13485) for its hemodialysis machine product.
As of 9:36 AM on the 1st, Sinopex was trading at 5,070 KRW, up 945 KRW (22.91%) compared to the previous trading day.
Sinopex announced that its "Sinopex Banggyo Plant" has obtained ISO13485 certification for the entire process of design, development, manufacturing, and distribution of hemodialysis machines for blood dialysis.
ISO13485 certification was acquired from the British Standards Institution (BSI), the world's most prestigious certification body known for its rigorous evaluation. This certification is expected to facilitate subsequent CE MDR product certification and U.S. FDA approval processes. Globally, ISO13485 is a fundamental requirement when introducing new medical device products in medical institutions such as university hospitals, serving as essential proof that the product meets international standards for quality, safety, and performance, making it a mandatory certification for entering the global market.
With this, Sinopex has secured a foothold not only in the domestic market but also for global market expansion. ISO13485 is an international medical device quality management system certification that adds special requirements for medical devices based on the ISO9001 quality management system certification.
According to the recently published Hemodialysis Global Market Report 2023, the global hemodialysis-related market is valued at 116 trillion KRW this year and is expected to rapidly grow to 143 trillion KRW by 2027.
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