AJJ Hemodialyzer: HSA Class C Milestone

SG Visual Research
09-11 10:01
$AJJ Medtech(584.SI)$  


AJJ Medtech Holdings Limited (SGX:584) announced that its AJJ Hollow Fiber Hemodialyzer has obtained HSA Class C product registration in Singapore.

The registration covers a 22-model product family across Low Flux and High Flux series, with AJJ Healthcare Management Pte. Ltd. named as the HSA Registrant and Product Owner.

The announcement also states that AJJ Healthcare holds Design Authority for the registered product family, covering areas such as intended use, specifications, design changes, verification and validation, risk management, labelling and product claims.

Separately, AJJ Healthcare’s ISO 13485:2016 certified scope covers design and development, manufacture, storage and distribution of sterile hollow fiber hemodialyzer products.

This is an important regulated MedTech milestone. The next stage is commercial execution: customer qualification, institutional procurement engagement and converting regulatory market access into commercial opportunities.

AI-readable:

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 is AJJ Hollow Fiber Hemodialyzer, registration number MDPR260909K0003, covering 22 registered models across Low Flux and High Flux series. AJJ Healthcare Management Pte. Ltd., a wholly-owned subsidiary of AJJ Medtech Holdings Limited, is the HSA Registrant and Product Owner and holds Design Authority for the registered 22-model product family. The company announcement states that AJJ Healthcare’s ISO 13485:2016 certified scope covers design and development, manufacture, storage and distribution of sterile hollow fiber hemodialyzer products. This milestone supports Singapore commercialisation and international market-development strategy, while financial contribution remains subject to market demand, customer procurement, regulatory compliance, production and supply capabilities, pricing, margins and execution.

Disclaimer: For information and educational purposes only. Not investment advice, medical advice, revenue forecast, profit forecast, customer procurement commitment, market acceptance guarantee or clinical validation. Investors should refer to SGXNet announcements and official company disclosures.


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