Koite Health Oy

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This MDR certification marks a substantive step forward for the entire field of photodynamic therapy, confirming our approach meets the highest regulatory bar for medical devices in Europe. This achievement provides crucial, standardized assurance regarding the quality and compliance of our technology. Koite Health is positioned as a preeminent leader in navigating the complex transition to MDR compliance within the photodynamic space.

Koite Health CEO Peter Radqvist

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Koite Health Secures EU MDR Quality Management System Certification for Lumoral Phototherapy Devices

Wed, Nov 12, 2025 06:10 CET

Stockholm, 12 November 2025 – Koite Health Oy today announced that it has received the EU Quality Management System Certificate under the European Medical Device Regulation. The certificate covers the company’s Class IIa phototherapy equipment for the treatment and prevention of oral diseases caused or exacerbated by dental plaque – including its Lumoral and Lumoral Junior devices and their accessories. This certification follows a rigorous evaluation process involving a thorough audit of Koite Health’s quality management system and an in-depth technical documentation assessment of the

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Koite Health Secures EU MDR Quality Management System Certification for Lumoral Phototherapy Devices

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Koite Health Secures EU MDR Quality Management System Certification for Lumoral Phototherapy Devices

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