Zhenjiang R&X Technology Co., Ltd.

Zhenjiang R&X Technology Co., Ltd. produces a range of Class I medical devices designed for therapeutic, mobility, and respiratory support. Their portfolio includes cushions for seating support, straight grab rails to assist mobility, massage balls for therapeutic use, kinesiology tape for musculoskeletal support, and a three-ball spirometer for respiratory function testing. These devices are intended for low-risk applications, such as pain relief, posture improvement, and basic mobility aid.

Zhenjiang R&X Technology Co., Ltd. is based in China. As a manufacturer, their location influences compliance with international regulatory standards, including those required for Class I devices under EU regulations. While the company operates from China, their devices must meet applicable regulatory requirements—such as those for EUDAMED registration—if marketed in the European Union, ensuring they align with safety and performance expectations regardless of origin.

Devices from Zhenjiang R&X Technology Co., Ltd. are registered in the EUDAMED database, which is the European Union’s medical device registry. Since their products are classified as Class I, they fall under the EU’s Medical Device Regulation (MDR) or previous directives, requiring mandatory listing in EUDAMED if placed on the EU market. This registry ensures transparency and traceability for authorized devices.

All devices produced by Zhenjiang R&X Technology Co., Ltd. are classified as Class I under EU medical device regulations. This classification applies to low-risk items like cushions, grab rails, massage balls, kinesiology tape, and spirometers, which pose minimal risk to patients. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories but still must comply with essential safety and performance requirements before authorization.