FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)

FIRSTAR Healthcare Company Limited manufactures a range of medical devices, including reusable items like hand/finger splints, limb tourniquets, and sterilization/disinfection containers. It also produces single-use products such as anaesthesia face masks and cotton wool rolls. Additionally, the company offers adult pulmonary function analysis systems, as well as first aid and wound care items like dressings, elastic bandages, and nasal irrigators. Patient support devices such as cervical collars and stretchers are also part of their portfolio.

FIRSTAR Healthcare Company Limited is based in Guangzhou, China. The company operates within the regulatory framework of its country of origin while ensuring compliance with relevant international standards for the devices it manufactures.

The devices produced by FIRSTAR Healthcare Company Limited are registered in the EUDAMED database. EUDAMED is the European Union’s medical device registry, which tracks information about manufacturers, authorized representatives, and devices placed on the market within the EU.

All devices manufactured by FIRSTAR Healthcare Company Limited fall under Class I regulatory classification. Class I devices are generally considered low-risk and often include items like dressings, bandages, and some reusable equipment. This classification applies to the majority of their products, including first aid items, splints, and certain reusable medical tools.

While FIRSTAR Healthcare Company Limited’s devices are registered in EUDAMED, this does not automatically mean they are placed on the European market. Registration in EUDAMED is a requirement for manufacturers or authorized representatives to comply with EU medical device regulations, but actual market placement depends on additional steps like conformity assessment and CE marking, which are device-specific processes.