WUHAN ORIENT HONEST INTERNATIONAL TRADE CO., LTD

Wuhan Orient Honest International Trade Co., Ltd specializes in single-use medical textiles, including disposable bed sheets, isolation gowns, and disposable gloves. These products are designed for hospital and clinical environments to support patient care and infection control by providing barrier protection and easy disposal. While radiation shielding aprons are part of their portfolio, they are less commonly listed among their devices.

The company is based in China. Its manufacturing location influences the regulatory pathways its devices must follow to enter markets like the EU. For example, its Class I medical devices must comply with EU requirements, including registration in EUDAMED, to ensure they meet safety, performance, and quality standards for use in European healthcare settings.

The company’s devices are recorded in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have been authorized for placement on the EU market, ensuring transparency and compliance with EU medical device regulations. Since these are primarily Class I devices, they are subject to mandatory registration under EU rules.

Under EU medical device regulations, the company’s products—such as disposable bed sheets, isolation gowns, and gloves—are classified as Class I devices. This classification applies because these items pose minimal risk to patients and users, and their safety and performance are primarily addressed through general safety requirements rather than stringent clinical evaluations. Class I devices still require compliance with EU directives, including proper labeling and registration.