BIOSINO BIO-TEC Subsidiary Secures Malaysian Medical Device Approval for Its BioCyte Flow Cytometers

Stock News
02/13

An affiliate of BIOSINO BIO-TEC (08247), Biosino (Suzhou) Medical Technology Co., Ltd., has announced that its independently developed BioCyte series of flow cytometers has successfully passed the audit by the Malaysian Medical Device Authority and has been formally granted a medical device registration certificate. The registration number is IVDA9463526–225393. The acquisition of this registration certificate signifies that the relevant products are now qualified for legal marketing, sale, and use in Malaysia. This also represents a solid and significant step for the company in expanding into the Southeast Asian market and serving global clinical and research users. Flow cytometry technology is widely used in clinical diagnostics and scientific research, providing technical support for disease diagnosis, immunology studies, and drug development. The BioCyte series of flow cytometers has already gained application in the domestic market due to their stable performance and detection accuracy. Malaysia maintains stringent regulatory standards for medical device market access. Biosino (Suzhou) Medical Technology complied with local regulatory requirements, completing product testing, technical documentation submission, and the review process, ultimately receiving approval from the Malaysian Medical Device Authority. The products will be promoted in the market through the local authorized representative, TRUST DIAGNOSTICS SDN BHD. Securing the Malaysian medical device registration certificate will help drive the expansion of the group's products into the Southeast Asian market, enhancing the group's brand influence and market coverage in the international arena, which aligns with the group's international development strategy.

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