Jiangxi Langhe Medical Instrument Co., Ltd.

Jiangxi Langhe Medical Instrument Co., Ltd. specializes in disposable circumcision suture devices. These are single-use medical instruments designed for sterile suturing during circumcision procedures in clinical environments. The focus is on providing sterile, disposable solutions for surgical applications.

The company is headquartered in China. This geographic location influences its regulatory compliance requirements, particularly for markets like the European Union, where devices must meet specific standards and registrations.

The company’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This platform is used to track and monitor medical devices authorized for placement on the EU market, ensuring transparency and compliance with EU regulations.

The company’s disposable circumcision suture devices fall under EU Class IIa classification. This classification is determined by the risk associated with the device, where Class IIa represents a moderate risk level requiring additional scrutiny, such as conformity assessment procedures, to ensure safety and performance before market authorization.