Lords Mark Renalyx Wins Licence to Make Class C World's First AI-Based Smart HemoDialysis Machines, Becomes World's 6th CE-Certified Brand

VMPL
New Delhi [India], December 10: Lords Mark Industries Ltd. (LMIL) has achieved a defining milestone in India's med-tech landscape by receiving the licence to manufacture Class C World's First AI-Based Smart HemodialysisMachines from the Central Drugs Standard Control Organisation (CDSCO), a critical step that significantly strengthens the country's self-reliance in life-saving healthcare technology.
This achievement becomes even more historic as LMIL-Renalyx has now received the globally recognised CE marking, making it one of only sixth brand worldwide to earn this certification for dialysis systems. The CE marking validates that the product meets the European Union's highest health, safety, and environmental protection standards, enabling legal access to the entire European Economic Area (EEA).
Securing a licence to manufacture Class C World's First AI-Based Smart Hemodialysis Machines is one of the toughest regulatory achievements in India's med-tech regime. Class C devices fall under the high-risk, life-sustaining category, which means even a minor engineering or process deviation can directly impact patient survival. To obtain this licence, companies must demonstrate full compliance across nearly 140+ quality, safety, and risk-management parameters, including biocompatibility proof, electromechanical safety validation, sterility assurance, traceability of every component, rigorous documentation, and multi-stage plant audits. Very few manufacturers attempt this category because the bar for approval is comparable to global regulatory standards. This certification is therefore critical: it is the formal authorisation that allows LMIL to build advanced renal-care equipment domestically, reduce national dependence on imported machines, and ensure that India's dialysis infrastructure is supported by globally benchmarked, fully compliant, life-saving technologies.
This achievement has come at a pivotal moment for India. The country's dialysis market valued at USD 5 billion in 2024, serves an estimated 18-20 lakh CKD patients, with 2.2-2.5 lakh new ESRD cases emerging annually. Yet India operates fewer than 6,000 dialysis centres, and demand for treatment is growing at 10-12% CAGR, while the nation remains heavily dependent on imported equipment.
At the heart of this breakthrough is LMIL's innovation ecosystem, which powers the World's First AI-Based Smart Hemodialysis Machines --developed jointly with Renalyx. This next-generation platform integrates AI-driven automation, predictive safety alerts, treatment optimisation, and real-time analytics to reduce human error and elevate clinical precision. The licence marks a major milestone in bringing this world-first technology to market at scale.
Strengthening its innovation pipeline, LMIL-Renalyx has expanded a specialised R&D ecosystem focused on future kidney-care technologies, liver-care engineering, advanced sensing systems, and data-driven renal informatics.
Commenting on this milestone, Sachidanand Upadhyay, Managing Director, Lords Mark Industries Ltd., said: "This licence is not just a regulatory approval, it's a recognition of India's ability to build and lead in the world's most advanced med-tech categories. With our AI-Driven smart Hemodialysis Machine and continuous R&D team efforts, we aim to redefine renal care globally. Our mission is to create intelligent, safe, and accessible healthcare technologies from India that can serve the world."
By becoming the first Indian company to manufacture an AI-Powered Smart Hemodialysis Machine, and by securing both the Indian manufacturing licence and global CE marking, LMIL-Renalyx has laid the foundation for a new era in Indian medical technology defined by innovation, quality, and global scalability.
For more details:- https://lordsmark.com/
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