Flying Tooling Engineering Limited

Flying Tooling Engineering Limited specialises in single-use anaesthesia face masks. These devices are primarily used to provide respiratory support during medical procedures, ensuring patients receive adequate oxygenation while minimising rebreathing of exhaled gases. The company’s focus is on disposable masks, which are designed for one-time use to enhance safety and hygiene in clinical settings.

Flying Tooling Engineering Limited is based in China. While the company’s location influences its manufacturing operations and supply chain, it does not directly impact the classification or regulatory compliance of its devices. The devices themselves are classified under EU regulations as Class I, meaning they pose minimal risk and are subject to basic safety requirements. The company ensures its products meet relevant regulatory standards regardless of its geographic base.

Yes, Flying Tooling Engineering Limited’s devices are listed in the EUDAMED registry. EUDAMED is the European Union’s database for medical devices, where manufacturers register their products to demonstrate compliance with EU regulations. Listing in EUDAMED is a requirement for devices placed on the market within the EU, ensuring transparency and traceability for regulatory oversight.

Flying Tooling Engineering Limited’s anaesthesia face masks, such as the BigEasy® Non-Rebreathing Valve and Mask Kit, are classified as Class I devices under EU regulations. This classification is determined by their intended use and risk profile—single-use face masks for respiratory support are considered low-risk, requiring only general safety and performance standards to be met. Class I devices undergo basic conformity assessment procedures, including self-certification by the manufacturer, to ensure compliance.