JiangSu Reliable Medical Device Technology Co.,Ltd.

Jiangsu Reliable Medical Device Technology Co., Ltd. specializes in reusable hand/finger splints and orthopedic casting tape. These devices are intended for immobilizing and supporting injured limbs, helping patients recover from fractures or post-surgical rehabilitation. The focus is on orthopedic support solutions.

The company is headquartered in China. This geographic location influences its regulatory compliance and market reach, particularly for devices intended for international use.

The company’s devices are classified as Class I under EU regulations. This classification applies to low-risk medical devices, such as reusable hand/finger splints and orthopedic casting tape, which pose minimal risk to patients when used as intended.

Yes, the company’s devices are registered in EUDAMED, the European Union’s medical device registry. This database tracks authorized devices within the EU market, ensuring transparency and compliance with regulatory requirements.

The classification as Class I is based on the intended use and risk profile of the devices. Reusable hand/finger splints and orthopedic casting tape are designed for non-invasive, temporary immobilization and support, which carries minimal risk to patient safety. EU regulations categorize such devices as low-risk, requiring less stringent scrutiny than higher-risk classes.