AOJ Medical, a leading innovator in medical technology, is proud to announce that it has officially received the EU Medical Device Regulation (MDR) CE Certification from SGS Finland for its flagship products: Compressor Nebulizers and Electric Breast Pumps.
The transition from MDD to the new EU MDR (2017/745) represents one of the most significant shifts in medical device regulation in decades. Achieving this certification is a testament to AOJ Medical’s ability to meet the highest safety and performance standards in the world.
Notably, our Compressor Nebulizers successfully navigated the complex and rigorous testing requirements of:
ISO 18562: Comprehensive evaluation of biocompatibility of breathing gas pathways.
ISO 27427: Strict verification of aerosol performance and particle deposition.
The journey to MDR compliance was a "marathon of precision." Despite the immense pressure of increased R&D costs and extended testing timelines, AOJ Medical refused to take shortcuts. This achievement underscores our "Hardcore Strength"—a result of years of investment in clinical evaluation, technical documentation, and quality management systems.
"Obtaining the MDR certificate is not the finish line; it is a new starting point for our global service mission," stated the leadership team at AOJ Medical. "This milestone provides our global distributors and healthcare partners with the ultimate confidence in our product safety and market longevity."
As the global medical landscape moves toward stricter compliance, AOJ Medical is positioned as a reliable, long-term partner for healthcare providers worldwide. This certification clears the path for expanded distribution across Europe and other international markets that recognize the gold standard of EU MDR.
Looking ahead, AOJ Medical will continue to prioritize innovation and clinical excellence, ensuring that our "Made in China" medical solutions deliver peace of mind to families and patients across the globe.
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