Polymatech Electronics Pioneers India’s First CDSCO-Registered Vein Finder with Indigenous Near-Infrared LED Technology
Chennai, India, Jan 06: Polymatech Electronics Limited has announced a major milestone for India’s medical device ecosystem with the successful registration and commencement of domestic manufacturing of its Vein Finder devices under the Medical Devices Rules, 2017. This development positions Polymatech as the first Indian manufacturer to offer a fully regulated, indigenously developed Vein Finder with a valid CDSCO Registration Number, integrated digital capabilities, and complete end-to-end domestic manufacturing.
The launch marks Polymatech’s strategic forward integration from a specialised chip and module manufacturer into a product-driven medical technology company. As part of this transition, the company has established a structured product roadmap and plans to introduce new technology products at six-month intervals, leveraging its core strengths in semiconductors, opto-electronics, and system-level integration.
Regulatory Compliance and Quality Assurance
Polymatech’s Vein Finder devices are registered with the Central Drugs Standard Control Organisation (CDSCO) as Class A (non-sterile, non-measuring) medical devices. In compliance with regulatory requirements, each unit is packaged with a clearly displayed CDSCO Registration Number, ensuring traceability, transparency, and regulatory compliance for clinical use across India.
The regulatory approval is supported by a robust, audited quality framework, including:
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ISO 13485:2016 – Quality Management System for Medical Devices
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ISO 9001:2015 – Quality Management System
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ISO 14001:2015 – Environmental Management System
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CE Compliance under the EU Low Voltage Directive (2014/35/EU) for electrical safety
Together, these certifications demonstrate Polymatech’s readiness to serve regulated domestic and international markets, while ensuring consistent standards of quality, safety, and environmental responsibility.
Until now, vein finder devices in India have largely been available through imports and reseller networks. Polymatech’s offering introduces the first fully regulated, Made-in-India alternative, reducing import dependence and strengthening national healthcare self-reliance.
Powered by Indigenous Innovation
At the heart of the Vein Finder is Polymatech’s proprietary Near-Infrared (NIR) LED platform, developed from the company’s in-house NIR chip expertise cultivated since 2021. The technology enables precise illumination control, high-contrast vein visualisation, and consistent clinical performance in a compact, handheld form factor.
Through vertical integration of NIR LEDs, electronics, and system design, Polymatech enhances supply-chain resilience while significantly reducing reliance on foreign components. Printed Circuit Boards (PCBs) are currently manufactured at Polymatech’s subsidiary in Estonia, with plans to transition production to Polymatech Industrial Park in Raipur, Chhattisgarh, supporting phased localisation under the Make in India initiative.
Designed for Clinical Excellence
Developed with direct inputs from healthcare professionals, the Vein Finder is optimised for real-world clinical workflows and features:
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Real-Time Projection: High-definition, on-skin vein visualisation
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Smart Connectivity: Secure wireless Bluetooth data transfer
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Digital Documentation: On-device storage of images and procedural session data
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Future-Ready Architecture: Designed to support analytics, training, and workflow evaluation
These non-invasive assistive capabilities help improve clinical efficiency, reduce multiple needle-stick attempts, and enhance overall patient comfort.
Commenting on the milestone, Mr. Eswara Rao Nandam, Managing Director & CEO, Polymatech Electronics Limited, said,
“This achievement underscores our commitment to building globally compliant medical devices in India. With CDSCO registration, internationally recognised ISO certifications, and CE compliance in place, we are enabling Indian healthcare institutions to access world-class medical technology manufactured domestically, while laying the foundation for structured expansion into global markets.”
Global Market Readiness and Expansion
With CDSCO registration secured and CE compliance established, Polymatech is actively advancing regulatory pathways for US FDA clearance, CE marking under the EU Medical Device Regulation (MDR), and country-specific approvals across Gulf Cooperation Council (GCC) and ASEAN markets. The company is preparing for a pan-India commercial rollout through authorised partners, alongside a phased entry into international markets.