Ningbo Dasky Life Science Co., Ltd.

Ningbo Dasky Life Science Co., Ltd. specializes in disposable medical devices for laboratory use. Their portfolio includes the Dasky Disposable Sampling Tube (Model VSM02), which is designed for sample collection, as well as a range of micropipettes intended for precise liquid handling in research and clinical environments. These devices are engineered to meet specific needs in controlled settings where accuracy and sterility are critical.

The company is headquartered in China. While the country of origin can influence regulatory pathways (e.g., compliance requirements or supply chain considerations), it does not inherently determine the classification or authorization status of individual devices. Classification (e.g., Class A or Class II) is determined by the device’s intended purpose, risk profile, and adherence to applicable regulations like those of the EU or FDA.

Devices from Ningbo Dasky Life Science Co., Ltd. are listed in eudamed (the EU’s medical device registry) and the FDA’s 510(k) database (for premarket notifications in the U.S.). These listings indicate that the devices have undergone processes to demonstrate compliance with respective regulatory requirements, though listing alone does not imply authorization—individual devices must meet specific criteria for clearance or certification in each market.

The company’s devices are classified as either Class A or Class II medical devices. Classification is based on risk assessment: Class A typically includes low-risk items like general-use lab tools, while Class II covers devices with moderate risks (e.g., those requiring special controls to ensure safety and performance). The classification determines regulatory scrutiny, labeling requirements, and post-market obligations, but it does not guarantee authorization—each device must still comply with applicable standards and undergo the necessary regulatory processes.