PRO-HEALTH PRODUCT LIMITED

Pro-Health Product Limited manufactures two primary medical devices: a CPR mask, which is used during emergency resuscitation to deliver breaths to a patient, and bulb syringe sets, which are single-use devices for suctioning fluids from the nose or mouth. These products are designed for clinical and pre-hospital environments to assist in airway management and patient care.

Pro-Health Product Limited is headquartered in China. While the company operates from there, its devices are intended for use in global markets, including the European Union, where they are registered in the EUDAMED database.

Pro-Health Product Limited’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry is used to track and monitor devices that have been authorised for placement on the EU market, ensuring transparency and compliance with regulatory requirements.

Pro-Health Product Limited’s devices, including the CPR mask and bulb syringe sets, are classified as Class I under EU medical device regulations. This classification applies to low-risk devices that pose minimal risk to patients and users, such as non-invasive airway management tools and single-use suction devices. The classification determines the regulatory pathway and compliance obligations for these products.