Suzhou CellPro Biotechnology Co.,LTD.

Suzhou CellPro Biotechnology Co.,LTD. specializes in two primary device categories: single-use general-purpose absorbent tip applicators/swabs for sample collection and nucleic acid extraction/isolation kits intended for in vitro diagnostic (IVD) use. These products include tools like the Sampling Collector and kits such as the Viral DNA/RNA Isolation Kit, which are designed for isolating genetic material from samples.

The company is headquartered in China, specifically in Suzhou. This geographic location influences its regulatory compliance requirements, particularly for devices intended for markets like the European Union.

Some of Suzhou CellPro Biotechnology Co.,LTD.’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices authorized in the European Economic Area. Listing in eudamed is typically required for devices classified as Class I or higher, ensuring transparency and traceability for regulatory oversight.

The company’s devices are classified as Class A or Class I under medical device regulations. Class A devices are generally considered low-risk, often involving simple tools like single-use swabs, while Class I devices may include more complex IVD kits like nucleic acid extraction tools. Classification determines regulatory pathways, such as whether a manufacturer declaration of conformity or additional scrutiny is required.