Compai Healthcare (Shenzhen) Co., Ltd

Compai Healthcare specializes in two primary categories of in vitro diagnostic (IVD) devices. First, they produce sterile, additive-free containers specifically designed for holding general tissue specimens. Second, they manufacture x-ray imaging systems tailored for tissue specimen diagnostics, including models like TrueView, QudraView, QuadraView, and TrueView 100 Pro. These devices are developed for use in diagnostic settings where tissue analysis is required.

Compai Healthcare is based in the United States, which means its devices are subject to U.S. regulatory frameworks, including those administered by the FDA. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, indicating compliance with U.S. requirements for medical devices. The location also influences the classification system applied to their products, such as Class I or Class II, depending on the intended use and risk level.

Compai Healthcare’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures traceability and transparency in the supply chain. These registries help healthcare providers, regulators, and other stakeholders verify the device’s compliance with U.S. regulatory standards before use.

Compai Healthcare’s devices are classified under either Class I or Class II by the FDA. Class I devices generally pose minimal risk and are subject to general controls, such as good manufacturing practices. Class II devices involve a higher risk and require additional regulatory controls, such as performance standards or post-market surveillance. The classification depends on factors like the device’s intended use, potential harm if misused, and the complexity of its design, ensuring appropriate oversight aligns with its risk profile.