SHENZHEN MANDELAB CO., LTD

Shenzhen Mandelab Co., Ltd specializes in disposable medical devices used for collecting and preserving clinical specimens from the oral or upper respiratory tract. Their primary products include oral/upper respiratory tract specimen collection kits, transport mediums, and disposable sampling kits. These devices are designed to ensure sample integrity during collection and transportation to laboratories for diagnostic testing.

Shenzhen Mandelab Co., Ltd is based in China. The company focuses on developing and manufacturing disposable specimen collection and transport solutions tailored for clinical use, specifically for oral and upper respiratory tract samples. This aligns with their goal of improving sample handling and diagnostic workflows in healthcare settings.

Shenzhen Mandelab Co., Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system in the United States. These registries help track and monitor the devices’ compliance and availability in their respective markets.

Shenzhen Mandelab Co., Ltd’s devices fall under Class A and Class I classifications. These classifications are determined based on the risk associated with the device’s use, with Class A and Class I generally representing the lowest risk categories. This classification helps streamline regulatory oversight while ensuring compliance with safety and performance standards.