Dear our valued customers,

GaleMed is pleased to announce that after extensive preparation, we have successfully achieved MDR (Medical Device Regulation) certification for a wide range of our respiratory care products:

• GaleMed’s Yilan factory is now certified under the MDR for Class I, Im, and IIa devices, Certificate No. HZ2100418-1.
• GaleMed’s Xiamen factory in China has obtained MDR certification for its Class IIa devices, Certificate No. HZ2058519-1.

As one of the pioneers in respiratory care solutions, GaleMed is proud of its commitment to delivering high-quality, regulatory-compliant medical devices. Our teams invested substantial resources and worked diligently to meet MDR standards, reflecting our dedication to ensuring patient safety and product excellence. 

With this achievement, GaleMed’s Yilan and Xiamen factories have collectively secured MDR certification for more than 40 EMDN codes and over 2,100 SKU product combinations. This certification covers all disposable and reusable accessories and components used in respiratory care. For further details on MDR certificates, please refer to the links to the Yilan Factory and Xiamen Factory.

We sincerely thank our valued partners and customers for their trust and support, enabling us to reach this significant milestone. GaleMed will continue to focus on providing innovative solutions to meet evolving market needs and strengthening our position as a leading provider of respiratory care products globally.

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