Shenzhen Fitconn Technology Co.,ltd

Shenzhen Fitconn Technology Co., Ltd. specializes in respiratory therapy devices, primarily producing compressor and mesh nebulizers. These devices are designed to aerosolize medication for inhalation, typically used at home for managing chronic respiratory conditions. The company also manufactures two branded inhaler systems, FEELO and SilMed, which are intended for controlled drug delivery.

The company is headquartered in Shenzhen, China. Its devices, including nebulizers and inhaler systems, are classified as Class IIa medical devices under EU regulations. These devices are listed in the EUDAQS database (eudamed), which is the official EU registry for medical devices, ensuring transparency and traceability for authorized products.

Shenzhen Fitconn Technology Co., Ltd.’s devices fall under Class IIa classification in the EU. This classification is determined based on the risk associated with the device’s intended use and design. Class IIa devices are considered to pose moderate risks and require compliance with specific regulatory requirements, including design controls, risk management, and clinical evaluations, to ensure safety and performance.

The company’s devices, such as its compressor and mesh nebulizers, are primarily designed for home use. These products are tailored for patients managing chronic respiratory conditions, enabling convenient and consistent medication delivery in a domestic setting. The inhaler systems (FEELO and SilMed) also follow this focus on patient-friendly, at-home respiratory care.