Haiyan Kangyuan Medical Instrument Co., Ltd. successfully obtained the European Union Medical Device Regulation 2017/745 (referred to as “MDR”) CE certification on July 19, 2023, certificate number 6122159CE01, the certification scope is Urinary Catheters for Single Use (Foley), Specifically includes 2 way silicone foley catheter, 3 way silicone foley catheter, 2 way silicone foley catheter with tiemann tip and 3 way silicone foley catheter with coude tip. At present, Kangyuan Medical has passed the MDR products:

Endotracheal Tubes for Single Use；

Sterile Suction Catheters for Single Use；

Oxygen Masks for Single Use;

Nasal Oxygen Cannulas for Single Use;

Guedel Airways for Single Use;

Laryngeal Mask Airways;

Anesthesia Masks for Single Use;

Breathing Filters for Single Use;

Breathing Circuits for Single Use;

Urinary Catheters for Single Use (Foley).

The EU MDR certification shows that Kangyuan Medical products meet the requirements of the latest EU medical device regulation 2017/745, have the latest access conditions of the EU market, and can continue to be legally sold in relevant overseas markets, laying a solid foundation for further entering the European market and promoting the internationalization process.