https://lmspiq.fda.gov.tw/web/MDPIQ/MDPIQ1000Result?licBaseId=E9E8CD1E-F83C-4F81-B7C9-60406E8E2472

Ministry of Health and Welfare Medical Device Registration No. 006010 

有效日期：20250520

BenQ Dialysis Technology Co., Ltd. 

68000817

ISO 13485

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Conduct microbial endotoxin testing, performance testing, mechanical testing, sterilization validation, etc., in accordance with ISO 13485 regulations.

Perform risk analysis and control in accordance with ISO 14971 and ISO 24971 regulations. Utilize relevant available information to identify potential hazards associated with medical devices, assess and control their risks, and monitor the effectiveness of these control measures to ensure that the safety risks of the medical devices remain within acceptable limits, protecting users and patients.

In accordance with ISO 13485 and local regulatory requirements, implement post-market surveillance and vigilance by collecting product manufacturing, usage experience, and issues after the medical device's market release, and conducting investigations. The gathered information is then fed back to relevant parties, and necessary actions are taken to ensure the safety and effectiveness of the medical device, prevent poor quality, and reduce the occurrence of injury events.

Republic of China Patent Certificate, Invention No. I 752542: dialyzer and dialyzer System.