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Press Release: UV Smart Receives TGA Approval, Reinforcing Global Regulatory Excellence

6/11/2025

UV Smart’s UV-C disinfection technology is now officially approved by the Australian Therapeutic Goods Administration (ARTG ID: 514485). This milestone expands the company’s global regulatory presence, joining existing ISO 13485, MDR, and MDSAP certifications. UV Smart continues to deliver validated, chemical-free UV-C disinfection solutions that support safer, more efficient, and sustainable healthcare worldwide.

Press Release: UV Smart Receives TGA Approval, Reinforcing Global Regulatory Excellence

Rijswijk, Netherlands – November 5, 2025 – UV Smart is proud to announce that its disinfection devices has officially received approval from the Australian Therapeutic Goods Administration (TGA), under ARTG ID: 514485. This milestone marks another significant step in UV Smart’s commitment to delivering safe, effective, and compliant disinfection technologies to healthcare providers worldwide.

The TGA approval validates the device’s safety and efficacy for use in Australian healthcare settings and further strengthens UV Smart’s global regulatory footprint.

“This approval reinforces our commitment to smarter, more sustainable healthcare,” said Thijs Kea, Co-Founder of UV Smart. “Our UV-C technology not only reduces infection risks, it lowers reliance on chemical disinfectants, cuts operational costs, and supports hospitals in meeting both environmental goals and budget targets. It’s a win for patients, providers, and the planet.”

Expanding Global Reach with Trusted Compliance

The TGA approval further strengthens UV Smart’s regulatory foundation and complements our existing MDSAP certification, which covers the regulatory requirements of Australia (TGA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA), and the USA (FDA). Combined with our MDR compliance and ISO 13485 certification, these approvals demonstrate the robustness of UV Smart’s Quality Management System (QMS) and our ability to consistently deliver high-quality medical devices across multiple global markets.

“Our team works tirelessly to ensure every product meets the highest standards of safety and performance,” said Deniz Duman, QA/RA Specialist at UV Smart. “This approval not only opens doors in Australia, but also reinforces the trust our partners place in our technologies.”

About UV Smart

UV Smart develops validated, chemical-free UV-C High-Level Disinfection technologies for non-critical and semi-critical medical devices. Designed for efficiency, traceability, and ease of use, UV Smart’s products empower healthcare professionals to achieve consistent, safe disinfection outcomes, while freeing up time to enhance patient care.

For more information, visit www.uvsmart.nl.

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