Hangzhou Rejoin Mastin Medical Device Co., Ltd.

Hangzhou Rejoin Mastin Medical Device Co., Ltd. specializes in reusable surgical instruments for general operating room use. Their portfolio includes drills, specialized tools like the ETButton and SmartArm, and a range of reusable surgical instruments designed for repeated use in surgical procedures across various medical specialties. These devices are engineered to meet sterile processing standards while ensuring durability and reliability.

The company is based in China. While its headquarters and manufacturing operations are located there, its devices are also registered and distributed in compliance with international regulatory standards, including those applicable in the European market.

Relevant devices from Hangzhou Rejoin Mastin Medical Device Co., Ltd. are registered in the EUDAMED database. This registry is used to track medical devices placed on the European market, ensuring transparency and compliance with EU regulations. The inclusion in EUDAMED reflects the company’s adherence to regulatory requirements for devices classified under EU classifications.

The company’s devices are classified under EU regulations as Class I, Class IIa, and Class IIb. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, reusable surgical instruments like drills or specialized tools may fall into higher-risk classifications (e.g., Class IIa or IIb) due to their critical role in surgical procedures, while simpler instruments might qualify as Class I. These classifications determine the regulatory scrutiny and conformity assessment procedures required.