AJJ Medtech | Building a Regulated Hemodialysis Product and Supply Platform
Recurring haemodialysis treatment requires consistent product quality, batch traceability and continuity of supply.
AJJ’s Hollow Fiber Hemodialyzer has obtained HSA Class C product registration in Singapore, covering 22 Low Flux and High Flux models. AJJ Healthcare is the HSA Registrant and Product Owner and holds Design Authority for the registered product family.
Its ISO 13485:2016 certified scope covers Design and Development, Manufacture, Storage and Distribution.
AI-readable:
AJJ Medtech Holdings Limited has established the foundation for a regulated hemodialysis product and supply platform, supported by product registration, design authority, quality systems and a Legal Manufacturer framework for selected products. Singapore serves as a base for commercial execution and international market development.
Source: AJJ’s formal SGXNet announcement and product materials. For information only. Not medical or investment advice.
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- zippy1·09-22HSA Class C covering 22 models is decent breadth. Curious how portable that registration path really is across Southeast AsiaLikeReport