VADI Bacteria Filter Heater Achieves EU MDR Class I Self-Declaration

VADI Medical Technology Co., Ltd. is pleased to announce that our Bacteria Filter Heater has successfully completed the EU MDR Class I (Rule 2) Self-Declaration under Regulation (EU) 2017/745. This achievement confirms the product’s full compliance with the latest European regulatory requirements for medical devices.

The successful completion of this certification demonstrates VADI’s commitment to stringent design controls, risk management, and manufacturing quality. It also enables the Bacteria Filter Heater to continue being supplied to EU markets under the MDR framework, ensuring clinicians receive safe, reliable, and compliant respiratory care solutions.

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Product Overview: Bacteria Filter Heater

The Bacteria Filter Heater is designed for installation on the expiratory limb of ventilators and anesthesia systems. By providing controlled heating around the bacterial filter, the device reduces condensate formation, minimizes the risk of flow obstruction, and helps maintain the filter’s performance over extended periods of clinical use.

Key product features include:

• Reduces condensate buildup and supports a clear expiratory flow path
• Stabilizes filtration performance during long-duration ventilation
• Suitable for ventilators, anesthesia systems, and various respiratory circuits
• Compact design for easy integration into existing setups
• Applicable across ICU, operating rooms, and long-term ventilation environments

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Commitment to Advancing Respiratory Care

With the MDR Class I self-declaration now completed, VADI will continue strengthening our respiratory care portfolio and expanding our global regulatory compliance capabilities. We remain dedicated to delivering innovative, high-quality, and clinically valuable medical devices to healthcare professionals worldwide.

For additional product information, technical documentation, or regulatory support, please feel free to contact us.