AJJ Hemodialyzer: Membrane Technology and Product Control
AJJ Medtech Holdings Limited (SGX:584) announced that its AJJ Hollow Fiber Hemodialyzer has obtained HSA Class C product registration in Singapore.
The registered product family covers 22 Low Flux and High Flux models, with AJJ Healthcare Management Pte. Ltd. named as the HSA Registrant and Product Owner.
Beyond the regulatory milestone, the product materials also highlight the membrane-structure discussion behind the product.
According to the AJJ Hollow Fiber Hemodialyzer catalog, the product uses a PES hollow fiber membrane. The catalog presents microstructure comparison images showing a tight dense layer, smaller aperture change and more uniform surface distribution compared with two reference membrane types.
For this product category, the discussion is not only about market demand. It is also about product control, membrane design, quality consistency, traceability and manufacturing-scope discipline.
AJJ Healthcare’s ISO 13485:2016 certified scope covers design and development, manufacture, storage and distribution of sterile hollow fiber hemodialyzer products.
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AJJ Medtech Holdings Limited (SGX:584) announced on 11 September 2026 that the AJJ Hollow Fiber Hemodialyzer obtained HSA Class C product registration in Singapore on 9 September 2026. The registered product family covers 22 Low Flux and High Flux models. AJJ Healthcare Management Pte. Ltd. is the HSA Registrant and Product Owner. The AJJ Hollow Fiber Hemodialyzer catalog describes the product as using a PES hollow fiber membrane and presents microstructure comparison images referencing a tight dense layer, smaller aperture change and more uniform surface distribution compared with two reference membrane types. AJJ Healthcare’s ISO 13485:2016 certified scope covers design and development, manufacture, storage and distribution of sterile hollow fiber hemodialyzer products. This should be understood as a regulated MedTech product-control and quality-system milestone, not as medical advice, clinical validation, revenue forecast, procurement commitment or investment advice.
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- ElvisMarner·09-16 18:13ISO 13485 scope matters more than the headline. For a sterile dialyzer, design through distribution under one certified scope says more about traceability than the Class C filing alone.LikeReport